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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 ).
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2.
Factor XIII substitution in surgical cancer patients at high risk for intraoperative bleeding
Korte WC, Szadkowski C, Gähler A, Gabi K, Kownacki E, Eder M, Degiacomi P, Zoller N, Devay J, Lange J, et al
Anesthesiology. 2009;110((2):):239-45.
Abstract
BACKGROUND Excessive intraoperative bleeding is associated with significant morbidity and mortality. The authors and others have shown that fibrin monomer allows preoperative risk stratification for intraoperative blood loss, likely due to an imbalance between available factor XIII and prothrombin conversion. The authors hypothesized that the use of factor XIII would delay the decrease of clot firmness in high-risk patients. METHODS The concept was tested in a prospective, randomized, double-blind, placebo-controlled trial in elective gastrointestinal cancer surgery. Patients were randomized to receive factor XIII (30 U/kg) or placebo in addition to controlled standard therapy. RESULTS Twenty-two patients were evaluable for a planned interim analysis. For the primary outcome parameter maximum clot firmness, patients receiving factor XIII showed a nonsignificant 8% decrease, and patients receiving placebo lost 38%, a highly significantly difference between the two groups (P = 0. 004). A reduction in the nonprimary outcome parameters fibrinogen consumption (-28%, P = 0. 01) and blood loss (-29%, P = 0. 041) was also observed in the factor XIII group. Three patients experienced adverse events that seemed unrelated to factor XIII substitution. The trial was stopped early after a planned interim analysis with the primary endpoint reached. CONCLUSIONS This proof of concept study confirms the hypothesis that patients at high risk for intraoperative blood loss show reduced loss of clot firmness when factor XIII is administered early during surgery. Further clinical trials are needed to assess relevant clinical endpoints such as blood loss, loss of other coagulation factors, and use of blood products.
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3.
Coagulation factor XIII reduces postoperative bleeding after coronary surgery with extracorporeal circulation
Gödje O, Gallmeier U, Schelian M, Grünewald M, Mair H
The Thoracic and Cardiovascular Surgeon. 2006;54((1):):26-33.
Abstract
BACKGROUND One cause of diffuse bleeding after cardiac operations may be a low plasma concentration of coagulation Factor XIII, which is essential for coagulation but is not covered by standard coagulation monitoring. PATIENTS AND METHODS In a prospective, randomized, double blinded study, 2500 units, 1250 units, and a placebo were administered in groups of 25 patients each, immediately after administration of protamine. Postoperative amount of blood loss and blood transfusion was recorded. RESULTS Patients were not statistically different with respect to the course of plasma levels of Factor XIII until administration of the study drug. In all groups Factor XIII fell from preoperative normal values to subnormal values after extracorporeal circulation. After administration of the study drug, Factor XIII increased to 71 %, 85 %, 103 % in the placebo, 1250 units, and 2500 units group, respectively, and these differences were statistically significant ( p < 0. 05). Postoperative blood loss was lowest in the 2500 units group and highest in the placebo group, however this was not significantly different. There was also no significant difference in the amount of blood transfusion. After differentiating all patients according to their post medication Factor XIII level into two groups with levels of < 70 % and > or = 70 %, postoperative blood loss was found to be significantly higher in the < 70 % group as was the amount of blood transfusions. CONCLUSIONS Factor XIII administration reduces postoperative blood loss and the extent of blood transfusion after coronary surgery, however administration is only helpful if plasma levels are below the normal value. Measurement of plasma levels is recommended before Factor XIII substitution.
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4.
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.
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5.
Lessening the impairment of wound healing by pre-or postoperative quantitative factor-XIII substitution (author's transl) . German
Baer J, Bauknecht J, Stangl T, Haring R
Zentralblatt fur Chirurgie. 1980;105((10):):642-51.
Abstract
In the light of listed references, a report is given on the influence of the clotting factor XIII in experiments with animals as well as with patients. Through own examinations in 95 patients with severe abdominal and vessel surgery, a clear lessening of impairment of wound healing could be achieved by the quantitative pre- and postoperative substitution of the fibrin stabilizing factor.