1.
Effect of early administration of coagulation factor XIII on fistula after pancreatic surgery: the FIPS randomized controlled trial
Takeda Y, Mise Y, Ishizuka N, Harada S, Hayama B, Inoue Y, Ishizawa T, Ito H, Takahashi Y, Saiura A
Langenbeck's archives of surgery. 2018
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 ).
2.
Factor XIII in the treatment of postoperative refractory wound-healing disorders. Results of a controlled study German
Mishima Y, Nagao F, Ishibiki K, Matsuda M, Nakamura N
Chirurg. 1984;55((12):):803-8.
Abstract
The efficacy of factor-XIII concentrate in the improvement of postoperative wound healing disorders (suture dehiscences, fistulae) was examined in 61 patients. In an open, randomised, and controlled trial the results (decrease of wound area, signs of inflammation, wound secretion, drainage volume, contrast x-ray films, and colour photos) were evaluated twice: open judgement by the clinicians themselves and blind judgement by an independent evaluation committee. The blind evaluation of the clinical data showed relevant general improvement in the patient groups treated with factor-XIII concentrate: 61.9% (dosage: 750 IU factor XIII for 3 days) and 76.2% (dosage: 1500 IU factor XIII for 3 days) as compared to 10.5% in the control group without factor XIII substitution. The differences were significant (Mann-Whitney-U-Test, p less than or equal to 0.001). These results would suggest substituting factor XIII activity in plasma above 70% of normal value in case of wound healing disorders.