Yoshinori Takeda1,2, Yoshihiro Mise1, Naoki Ishizuka3, Sohei Harada4, Brian Hayama4, Yosuke Inoue1, Takeaki Ishizawa1, Hiromichi Ito1, Yu Takahashi1, Akio Saiura5. 1. Department of Hepatobiliary-Pancreatic Surgery, Japanese Foundation for Cancer Research, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. 2. Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine, Tokyo, Japan. 3. Clinical Research and Medical Development Center, Japanese Foundation for Cancer Research, Cancer Institute Hospital, Tokyo, Japan. 4. Department of Infectious Diseases, Japanese Foundation for Cancer Research, Cancer Institute Hospital, Tokyo, Japan. 5. Department of Hepatobiliary-Pancreatic Surgery, Japanese Foundation for Cancer Research, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. akio.saiura@jfcr.or.jp.
Abstract
PURPOSE: The 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). METHODS: A 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). RESULTS:Fifty 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. CONCLUSION: Early administration of exogenous FXIII does not facilitate the healing of POPF. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN) Center (UMIN000019480, http://www.umin.ac.jp ).
RCT Entities:
PURPOSE: The 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). METHODS: A 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). RESULTS: Fifty 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. CONCLUSION: Early administration of exogenous FXIII does not facilitate the healing of POPF. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN) Center (UMIN000019480, http://www.umin.ac.jp ).
Entities:
Keywords:
Coagulation factor XIII; Early cure; Postoperative pancreatic fistula; RCT
Authors: Christian Kleber; Armin Sablotzki; Sebastian Casu; Martin Olivieri; Kai-Martin Thoms; Johannes Horter; Felix C F Schmitt; Ingvild Birschmann; Dietmar Fries; Marc Maegele; Herbert Schöchl; Michaela Wilhelmi Journal: Crit Care Date: 2022-03-24 Impact factor: 19.334