Effect of early administration of coagulation factor XIII on fistula after pancreatic surgery: the FIPS randomized controlled trial View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-11-30

AUTHORS

Yoshinori Takeda, Yoshihiro Mise, Naoki Ishizuka, Sohei Harada, Brian Hayama, Yosuke Inoue, Takeaki Ishizawa, Hiromichi Ito, Yu Takahashi, Akio Saiura

ABSTRACT

PurposeThe administration of exogenous factor XIII (FXIII) is reportedly effective for fistula closure in patients with a low plasma FXIII level. This study was performed to analyze the effect of early administration of exogenous FXIII on postoperative pancreatic fistula (POPF).MethodsA single-center randomized controlled, open-label, parallel group, superiority trial was conducted from October 2015 to August 2016 in Japan. Patients with POPF and a plasma FXIII level of ≤ 70% on postoperative day 7 were randomly assigned to an early replacement (ER) group or control group in a 1:1 ratio by an independent coordinator using a computer-generated random number table. The ER group received FXIII concentrate the day after randomization, and the control group received no FXIII concentrate within 2 weeks. The primary endpoint was the duration of drain placement from randomization (DDPR).ResultsFifty patients were randomized (ER group, 24; control group, 26), and all were analyzed with an intention-to-treat approach. There was no significant difference in the DDPR between the two groups (18 vs. 16 days; hazard ratio, 1.45; 95% confidence interval, 0.813–2.583). No serious harm was reported in either group.ConclusionEarly administration of exogenous FXIII does not facilitate the healing of POPF.Trial registrationUniversity Hospital Medical Information Network (UMIN) Center (UMIN000019480, http://www.umin.ac.jp). More... »

PAGES

933-940

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00423-018-1736-4

DOI

http://dx.doi.org/10.1007/s00423-018-1736-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1110279916

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30506109


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