Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2012-12

AUTHORS

Ofer Nativ, Bababhai Patel, Jessica Shen, Jonathan Batiller, Sara Horn, James C Hart

ABSTRACT

BACKGROUND: Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. METHODS: We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product-fibrin pad-to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. RESULTS: Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3-4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. CONCLUSIONS: The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. TRIAL REGISTRATION: Phase I/II trial, NCT00598130. More... »

PAGES

147

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1471-2369-13-147

DOI

http://dx.doi.org/10.1186/1471-2369-13-147

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1048554648

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23137020


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Adolescent", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Adult", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Cohort Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Female", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Fibrin Tissue Adhesive", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Follow-Up Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Hemostatics", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Male", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Middle Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Nephrectomy", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Prospective Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Single-Blind Method", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Standard of Care", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Treatment Outcome", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Young Adult", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Bnai Zion Medical Center", 
          "id": "https://www.grid.ac/institutes/grid.414529.f", 
          "name": [
            "Bnai Zion Medical Center, Haifa, Israel"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nativ", 
        "givenName": "Ofer", 
        "id": "sg:person.0600752561.64", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0600752561.64"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Johnson & Johnson (United States)", 
          "id": "https://www.grid.ac/institutes/grid.417429.d", 
          "name": [
            "Ethicon, Inc, A Johnson and Johnson Company, P. O. Box #151, 08876-0151, Somerville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Patel", 
        "givenName": "Bababhai", 
        "id": "sg:person.01275446460.95", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01275446460.95"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Johnson & Johnson (United States)", 
          "id": "https://www.grid.ac/institutes/grid.417429.d", 
          "name": [
            "Ethicon, Inc, A Johnson and Johnson Company, P. O. Box #151, 08876-0151, Somerville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Shen", 
        "givenName": "Jessica", 
        "id": "sg:person.01342236650.33", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01342236650.33"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Johnson & Johnson (United States)", 
          "id": "https://www.grid.ac/institutes/grid.417429.d", 
          "name": [
            "Ethicon, Inc, A Johnson and Johnson Company, P. O. Box #151, 08876-0151, Somerville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Batiller", 
        "givenName": "Jonathan", 
        "id": "sg:person.0616632550.63", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0616632550.63"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Johnson & Johnson (Israel)", 
          "id": "https://www.grid.ac/institutes/grid.474389.5", 
          "name": [
            "Omrix Biopharmaceuticals Ltd, Kiryat Ono, Israel"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Horn", 
        "givenName": "Sara", 
        "id": "sg:person.014760350273.44", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014760350273.44"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Johnson & Johnson (United States)", 
          "id": "https://www.grid.ac/institutes/grid.417429.d", 
          "name": [
            "Ethicon, Inc, A Johnson and Johnson Company, P. O. Box #151, 08876-0151, Somerville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hart", 
        "givenName": "James C", 
        "id": "sg:person.01345231446.54", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01345231446.54"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "https://doi.org/10.1016/j.eururo.2005.10.020", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000858101"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1464-410x.2008.08035.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1002726651"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0022-5347(05)67328-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1002964717"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmoa041031", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1005610447"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0741-5214(99)70073-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1012456353"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.4065/75.12.1236", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1012653938"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1213/ane.0b013e3181c92b23", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014982118"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1213/ane.0b013e3181c92b23", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014982118"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1213/ane.0b013e3181c92b23", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014982118"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.surg.2007.06.023", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1015568730"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.ejcts.2003.11.018", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1016869369"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.eururo.2010.05.047", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1017690262"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.juro.2009.12.030", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1027510671"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0090-4295(02)02143-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1028690033"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0090-4295(02)02143-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1028690033"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3349/ymj.1991.32.1.53", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1034382242"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1155/2008/916463", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1034915002"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0022-5223(98)70370-8", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1036115825"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.eururo.2007.04.027", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1039755182"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0090-4295(02)01501-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1042634897"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.eururo.2007.02.035", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1043639508"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00423-005-0543-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1043671727", 
          "https://doi.org/10.1007/s00423-005-0543-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0002-9610(01)00773-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1043777515"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/01.ju.0000154165.12738.7f", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044682355"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/01.ju.0000154165.12738.7f", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044682355"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/01.ju.0000154165.12738.7f", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044682355"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jss.2010.01.022", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044790020"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/bjs.7235", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1045905805"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/bjs.7235", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1045905805"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/00001721-199707000-00001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1047330943"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/00001721-199707000-00001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1047330943"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1046/j.1524-4725.1999.8228a.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1049866654"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1046/j.1524-4725.1999.8228a.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1049866654"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/jbm.b.30916", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050834125"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1089/end.2006.0265", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1059257208"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3171/2010.8.peds10248", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1071076027"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3171/2010.8.peds10248", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1071076027"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3171/2010.8.peds10248", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1071076027"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3171/2010.8.peds10248", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1071076027"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3171/2010.8.peds10248", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1071076027"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1077923541", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1082404741", 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2012-12", 
    "datePublishedReg": "2012-12-01", 
    "description": "BACKGROUND: Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages.\nMETHODS: We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product-fibrin pad-to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N\u2009=\u200910), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N\u2009=\u20097) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10\u2009min following randomization, analyzed by Fisher exact tests at 5% significance level.\nRESULTS: Phase I (N\u2009=\u200910): All patients completed the study. Hemostasis was achieved within 3-4\u2009min (average\u2009=\u20093.1\u2009min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N\u2009=\u20097): Hemostatic success at 10\u2009min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled.\nCONCLUSIONS: The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage.\nTRIAL REGISTRATION: Phase I/II trial, NCT00598130.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1186/1471-2369-13-147", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1024626", 
        "issn": [
          "1471-2369"
        ], 
        "name": "BMC Nephrology", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "13"
      }
    ], 
    "name": "Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study", 
    "pagination": "147", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "e74e63c47b68767667b282b7fb3a6d3105909a153453eba01829a6ee2b6f0059"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "23137020"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "100967793"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/1471-2369-13-147"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1048554648"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/1471-2369-13-147", 
      "https://app.dimensions.ai/details/publication/pub.1048554648"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-10T17:38", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000001_0000000264/records_8672_00000551.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "http://link.springer.com/10.1186%2F1471-2369-13-147"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/1471-2369-13-147'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/1471-2369-13-147'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/1471-2369-13-147'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/1471-2369-13-147'


 

This table displays all metadata directly associated to this object as RDF triples.

266 TRIPLES      21 PREDICATES      76 URIs      38 LITERALS      26 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/1471-2369-13-147 schema:about N026577db8c3a43119a200991e5a516d8
2 N16b67b46132b495290d35e79796b4f56
3 N1c7440e96edf424abcbb11eb28c351e0
4 N25e40b788e214534af341adb26570f7c
5 N3c4367fdee8746f69ccceb72f88e6153
6 N434a43ae62144f3080a1cba0a6d790db
7 N5bd17a1ecf9048b6828c80d34131ef27
8 N739295c8bc68437c8a1b3c7c7103dd7b
9 N75209122e0a044859589121838a8c6b9
10 N78f7103965c844c794c6a2fd01d59ad3
11 N866863b685cb462983c5b89bba9c3e0e
12 N96ce6215c43449f1b43c57c3c92e0cc4
13 Nb9463796ee744b76bfad80271fa203ce
14 Nbfa03ca50c5a4f1781595f9f4232f11c
15 Nc7dd6c9db88442858f2a0f4e9276ba8b
16 Ndb4336e98edb49499fc12333afdf5441
17 Nf13b26128f2f4f1d8935a85f57f93621
18 anzsrc-for:11
19 anzsrc-for:1103
20 schema:author Ne8731d45d1844a72be365ea92df76f02
21 schema:citation sg:pub.10.1007/s00423-005-0543-x
22 https://app.dimensions.ai/details/publication/pub.1077923541
23 https://app.dimensions.ai/details/publication/pub.1082404741
24 https://doi.org/10.1002/bjs.7235
25 https://doi.org/10.1002/jbm.b.30916
26 https://doi.org/10.1016/j.ejcts.2003.11.018
27 https://doi.org/10.1016/j.eururo.2005.10.020
28 https://doi.org/10.1016/j.eururo.2007.02.035
29 https://doi.org/10.1016/j.eururo.2007.04.027
30 https://doi.org/10.1016/j.eururo.2010.05.047
31 https://doi.org/10.1016/j.jss.2010.01.022
32 https://doi.org/10.1016/j.juro.2009.12.030
33 https://doi.org/10.1016/j.surg.2007.06.023
34 https://doi.org/10.1016/s0002-9610(01)00773-5
35 https://doi.org/10.1016/s0022-5223(98)70370-8
36 https://doi.org/10.1016/s0022-5347(05)67328-4
37 https://doi.org/10.1016/s0090-4295(02)01501-7
38 https://doi.org/10.1016/s0090-4295(02)02143-x
39 https://doi.org/10.1016/s0741-5214(99)70073-x
40 https://doi.org/10.1046/j.1524-4725.1999.8228a.x
41 https://doi.org/10.1056/nejmoa041031
42 https://doi.org/10.1089/end.2006.0265
43 https://doi.org/10.1097/00001721-199707000-00001
44 https://doi.org/10.1097/01.ju.0000154165.12738.7f
45 https://doi.org/10.1111/j.1464-410x.2008.08035.x
46 https://doi.org/10.1155/2008/916463
47 https://doi.org/10.1213/ane.0b013e3181c92b23
48 https://doi.org/10.3171/2010.8.peds10248
49 https://doi.org/10.3349/ymj.1991.32.1.53
50 https://doi.org/10.4065/75.12.1236
51 schema:datePublished 2012-12
52 schema:datePublishedReg 2012-12-01
53 schema:description BACKGROUND: Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. METHODS: We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product-fibrin pad-to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. RESULTS: Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3-4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. CONCLUSIONS: The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. TRIAL REGISTRATION: Phase I/II trial, NCT00598130.
54 schema:genre research_article
55 schema:inLanguage en
56 schema:isAccessibleForFree true
57 schema:isPartOf N59130da1f08644299d0a1937319edc49
58 N9361c1b200a5481b9994d73c7ec1509e
59 sg:journal.1024626
60 schema:name Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study
61 schema:pagination 147
62 schema:productId N08d12dde801a4da693b5e0640158a1fd
63 N18cabf0d42e740579a7ec97becd47536
64 N40ac1a9f57ed4d6ca804d787ee322fab
65 Nae7016d30c304e958f3aebad237943a6
66 Ne1b5c4784aea47cb8f0fe465a3171a10
67 schema:sameAs https://app.dimensions.ai/details/publication/pub.1048554648
68 https://doi.org/10.1186/1471-2369-13-147
69 schema:sdDatePublished 2019-04-10T17:38
70 schema:sdLicense https://scigraph.springernature.com/explorer/license/
71 schema:sdPublisher N991c96a7b912413cb79259529d35ffdf
72 schema:url http://link.springer.com/10.1186%2F1471-2369-13-147
73 sgo:license sg:explorer/license/
74 sgo:sdDataset articles
75 rdf:type schema:ScholarlyArticle
76 N026577db8c3a43119a200991e5a516d8 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
77 schema:name Fibrin Tissue Adhesive
78 rdf:type schema:DefinedTerm
79 N08d12dde801a4da693b5e0640158a1fd schema:name nlm_unique_id
80 schema:value 100967793
81 rdf:type schema:PropertyValue
82 N16b67b46132b495290d35e79796b4f56 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
83 schema:name Male
84 rdf:type schema:DefinedTerm
85 N18cabf0d42e740579a7ec97becd47536 schema:name pubmed_id
86 schema:value 23137020
87 rdf:type schema:PropertyValue
88 N1c7440e96edf424abcbb11eb28c351e0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
89 schema:name Young Adult
90 rdf:type schema:DefinedTerm
91 N25e40b788e214534af341adb26570f7c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
92 schema:name Cohort Studies
93 rdf:type schema:DefinedTerm
94 N336cd79e8de245cebd64d79d3c58417e rdf:first sg:person.0616632550.63
95 rdf:rest Nb650c1bea49c4b3e94d59adbc6105455
96 N3c4367fdee8746f69ccceb72f88e6153 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
97 schema:name Adult
98 rdf:type schema:DefinedTerm
99 N40ac1a9f57ed4d6ca804d787ee322fab schema:name doi
100 schema:value 10.1186/1471-2369-13-147
101 rdf:type schema:PropertyValue
102 N434a43ae62144f3080a1cba0a6d790db schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
103 schema:name Hemostatics
104 rdf:type schema:DefinedTerm
105 N59130da1f08644299d0a1937319edc49 schema:volumeNumber 13
106 rdf:type schema:PublicationVolume
107 N5bd17a1ecf9048b6828c80d34131ef27 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
108 schema:name Middle Aged
109 rdf:type schema:DefinedTerm
110 N739295c8bc68437c8a1b3c7c7103dd7b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
111 schema:name Adolescent
112 rdf:type schema:DefinedTerm
113 N75209122e0a044859589121838a8c6b9 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
114 schema:name Standard of Care
115 rdf:type schema:DefinedTerm
116 N78f7103965c844c794c6a2fd01d59ad3 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
117 schema:name Female
118 rdf:type schema:DefinedTerm
119 N866863b685cb462983c5b89bba9c3e0e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
120 schema:name Single-Blind Method
121 rdf:type schema:DefinedTerm
122 N9361c1b200a5481b9994d73c7ec1509e schema:issueNumber 1
123 rdf:type schema:PublicationIssue
124 N96ce6215c43449f1b43c57c3c92e0cc4 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
125 schema:name Treatment Outcome
126 rdf:type schema:DefinedTerm
127 N991c96a7b912413cb79259529d35ffdf schema:name Springer Nature - SN SciGraph project
128 rdf:type schema:Organization
129 Nae7016d30c304e958f3aebad237943a6 schema:name readcube_id
130 schema:value e74e63c47b68767667b282b7fb3a6d3105909a153453eba01829a6ee2b6f0059
131 rdf:type schema:PropertyValue
132 Nb207a36d15f84f0e8b80b66711e690d2 rdf:first sg:person.01342236650.33
133 rdf:rest N336cd79e8de245cebd64d79d3c58417e
134 Nb650c1bea49c4b3e94d59adbc6105455 rdf:first sg:person.014760350273.44
135 rdf:rest Ncc5bc4c819d841c9a764293b85559766
136 Nb9463796ee744b76bfad80271fa203ce schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
137 schema:name Aged
138 rdf:type schema:DefinedTerm
139 Nbfa03ca50c5a4f1781595f9f4232f11c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
140 schema:name Nephrectomy
141 rdf:type schema:DefinedTerm
142 Nc5ff7c1173d745918b1049830a601901 rdf:first sg:person.01275446460.95
143 rdf:rest Nb207a36d15f84f0e8b80b66711e690d2
144 Nc7dd6c9db88442858f2a0f4e9276ba8b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
145 schema:name Follow-Up Studies
146 rdf:type schema:DefinedTerm
147 Ncc5bc4c819d841c9a764293b85559766 rdf:first sg:person.01345231446.54
148 rdf:rest rdf:nil
149 Ndb4336e98edb49499fc12333afdf5441 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
150 schema:name Prospective Studies
151 rdf:type schema:DefinedTerm
152 Ne1b5c4784aea47cb8f0fe465a3171a10 schema:name dimensions_id
153 schema:value pub.1048554648
154 rdf:type schema:PropertyValue
155 Ne8731d45d1844a72be365ea92df76f02 rdf:first sg:person.0600752561.64
156 rdf:rest Nc5ff7c1173d745918b1049830a601901
157 Nf13b26128f2f4f1d8935a85f57f93621 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
158 schema:name Humans
159 rdf:type schema:DefinedTerm
160 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
161 schema:name Medical and Health Sciences
162 rdf:type schema:DefinedTerm
163 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
164 schema:name Clinical Sciences
165 rdf:type schema:DefinedTerm
166 sg:journal.1024626 schema:issn 1471-2369
167 schema:name BMC Nephrology
168 rdf:type schema:Periodical
169 sg:person.01275446460.95 schema:affiliation https://www.grid.ac/institutes/grid.417429.d
170 schema:familyName Patel
171 schema:givenName Bababhai
172 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01275446460.95
173 rdf:type schema:Person
174 sg:person.01342236650.33 schema:affiliation https://www.grid.ac/institutes/grid.417429.d
175 schema:familyName Shen
176 schema:givenName Jessica
177 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01342236650.33
178 rdf:type schema:Person
179 sg:person.01345231446.54 schema:affiliation https://www.grid.ac/institutes/grid.417429.d
180 schema:familyName Hart
181 schema:givenName James C
182 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01345231446.54
183 rdf:type schema:Person
184 sg:person.014760350273.44 schema:affiliation https://www.grid.ac/institutes/grid.474389.5
185 schema:familyName Horn
186 schema:givenName Sara
187 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014760350273.44
188 rdf:type schema:Person
189 sg:person.0600752561.64 schema:affiliation https://www.grid.ac/institutes/grid.414529.f
190 schema:familyName Nativ
191 schema:givenName Ofer
192 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0600752561.64
193 rdf:type schema:Person
194 sg:person.0616632550.63 schema:affiliation https://www.grid.ac/institutes/grid.417429.d
195 schema:familyName Batiller
196 schema:givenName Jonathan
197 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0616632550.63
198 rdf:type schema:Person
199 sg:pub.10.1007/s00423-005-0543-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1043671727
200 https://doi.org/10.1007/s00423-005-0543-x
201 rdf:type schema:CreativeWork
202 https://app.dimensions.ai/details/publication/pub.1077923541 schema:CreativeWork
203 https://app.dimensions.ai/details/publication/pub.1082404741 schema:CreativeWork
204 https://doi.org/10.1002/bjs.7235 schema:sameAs https://app.dimensions.ai/details/publication/pub.1045905805
205 rdf:type schema:CreativeWork
206 https://doi.org/10.1002/jbm.b.30916 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050834125
207 rdf:type schema:CreativeWork
208 https://doi.org/10.1016/j.ejcts.2003.11.018 schema:sameAs https://app.dimensions.ai/details/publication/pub.1016869369
209 rdf:type schema:CreativeWork
210 https://doi.org/10.1016/j.eururo.2005.10.020 schema:sameAs https://app.dimensions.ai/details/publication/pub.1000858101
211 rdf:type schema:CreativeWork
212 https://doi.org/10.1016/j.eururo.2007.02.035 schema:sameAs https://app.dimensions.ai/details/publication/pub.1043639508
213 rdf:type schema:CreativeWork
214 https://doi.org/10.1016/j.eururo.2007.04.027 schema:sameAs https://app.dimensions.ai/details/publication/pub.1039755182
215 rdf:type schema:CreativeWork
216 https://doi.org/10.1016/j.eururo.2010.05.047 schema:sameAs https://app.dimensions.ai/details/publication/pub.1017690262
217 rdf:type schema:CreativeWork
218 https://doi.org/10.1016/j.jss.2010.01.022 schema:sameAs https://app.dimensions.ai/details/publication/pub.1044790020
219 rdf:type schema:CreativeWork
220 https://doi.org/10.1016/j.juro.2009.12.030 schema:sameAs https://app.dimensions.ai/details/publication/pub.1027510671
221 rdf:type schema:CreativeWork
222 https://doi.org/10.1016/j.surg.2007.06.023 schema:sameAs https://app.dimensions.ai/details/publication/pub.1015568730
223 rdf:type schema:CreativeWork
224 https://doi.org/10.1016/s0002-9610(01)00773-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1043777515
225 rdf:type schema:CreativeWork
226 https://doi.org/10.1016/s0022-5223(98)70370-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1036115825
227 rdf:type schema:CreativeWork
228 https://doi.org/10.1016/s0022-5347(05)67328-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1002964717
229 rdf:type schema:CreativeWork
230 https://doi.org/10.1016/s0090-4295(02)01501-7 schema:sameAs https://app.dimensions.ai/details/publication/pub.1042634897
231 rdf:type schema:CreativeWork
232 https://doi.org/10.1016/s0090-4295(02)02143-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1028690033
233 rdf:type schema:CreativeWork
234 https://doi.org/10.1016/s0741-5214(99)70073-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1012456353
235 rdf:type schema:CreativeWork
236 https://doi.org/10.1046/j.1524-4725.1999.8228a.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1049866654
237 rdf:type schema:CreativeWork
238 https://doi.org/10.1056/nejmoa041031 schema:sameAs https://app.dimensions.ai/details/publication/pub.1005610447
239 rdf:type schema:CreativeWork
240 https://doi.org/10.1089/end.2006.0265 schema:sameAs https://app.dimensions.ai/details/publication/pub.1059257208
241 rdf:type schema:CreativeWork
242 https://doi.org/10.1097/00001721-199707000-00001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1047330943
243 rdf:type schema:CreativeWork
244 https://doi.org/10.1097/01.ju.0000154165.12738.7f schema:sameAs https://app.dimensions.ai/details/publication/pub.1044682355
245 rdf:type schema:CreativeWork
246 https://doi.org/10.1111/j.1464-410x.2008.08035.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1002726651
247 rdf:type schema:CreativeWork
248 https://doi.org/10.1155/2008/916463 schema:sameAs https://app.dimensions.ai/details/publication/pub.1034915002
249 rdf:type schema:CreativeWork
250 https://doi.org/10.1213/ane.0b013e3181c92b23 schema:sameAs https://app.dimensions.ai/details/publication/pub.1014982118
251 rdf:type schema:CreativeWork
252 https://doi.org/10.3171/2010.8.peds10248 schema:sameAs https://app.dimensions.ai/details/publication/pub.1071076027
253 rdf:type schema:CreativeWork
254 https://doi.org/10.3349/ymj.1991.32.1.53 schema:sameAs https://app.dimensions.ai/details/publication/pub.1034382242
255 rdf:type schema:CreativeWork
256 https://doi.org/10.4065/75.12.1236 schema:sameAs https://app.dimensions.ai/details/publication/pub.1012653938
257 rdf:type schema:CreativeWork
258 https://www.grid.ac/institutes/grid.414529.f schema:alternateName Bnai Zion Medical Center
259 schema:name Bnai Zion Medical Center, Haifa, Israel
260 rdf:type schema:Organization
261 https://www.grid.ac/institutes/grid.417429.d schema:alternateName Johnson & Johnson (United States)
262 schema:name Ethicon, Inc, A Johnson and Johnson Company, P. O. Box #151, 08876-0151, Somerville, NJ, USA
263 rdf:type schema:Organization
264 https://www.grid.ac/institutes/grid.474389.5 schema:alternateName Johnson & Johnson (Israel)
265 schema:name Omrix Biopharmaceuticals Ltd, Kiryat Ono, Israel
266 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...