Authors
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José Carlos Rodrigues Nascimento -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2023
INTERVENTION: D02.241.081.193.150.075 Patients were randomized into 2 groups. 24 patients received aminocaproic acid (20 mg/kg/h), in a total of 500ml containing 10 grams of aminocaproic acid, in a continuous intravenous infusion pump, in a single dose, only during liver transplantation and 26 patients received a similar volume of 500 ml of 0.9% saline solution, which was used as a placebo at the same time interval as the administration of epsilon aminocaproic acid. Randomization was double‐blind in a sealed envelope. Neither surgeons nor anesthesiologists were aware in which group the patients were allocated. CONDITION: E02.095.147 Liver transplantation; Fibrinolysis PRIMARY OUTCOME: It is expected to find a difference between the means of at least 5% of maximum lysis in the anhepatic phase between the intervention and control groups, verified using the Two‐way ANOVA method and Bonferroni posttests. Using Two‐way ANOVA and Bonferroni posttests, we observed a 15% reduction in mean hyperfibrinolysis in the group of patients treated with epsilon aminocaproic acid (P<0.001) when compared to those in the control group during the anhepatic phase. INCLUSION CRITERIA: Patients undergoing liver transplantation; both sexes; age from 18 years SECONDARY OUTCOME: Identify any difference between the proportions or means of patients who were discharged from hospital and those who died within 2 months after liver transplantation in both groups, verified using the Fisher's or Mann‐Whitney method. It is expected to find a difference between the proportions or means of transfusion of blood products and/or the administration of hemostatic products of at least 5%, using the Fisher's or Mann‐Whitney method. As well as the percentage of patients who received a transfusion of blood products and/or hemostatic products, both intraoperatively and within 24 hours postoperatively, verified using the Two‐way ANOVA method and Bonferroni posttests. It is expected to find a difference of at least 5% between the proportions or means of postoperative complications such as pulmonary infection, acute rejection, hepatic artery thrombosis, sepsis, reoperation within 24 hours of the postoperative period and acute renal failure between groups, verified using the Fisher's or Mann‐Whitney method. The other EXTEM and FIBTEM analyses are expected to show a difference of at least 5%, verified using the Two‐way ANOVA method and Bonferroni posttests. ; Using the Fisher's or Mann‐Whitney method, no significant difference was observed regarding patients who were discharged from hospital and those who died within 2 months after liver transplantation in both groups. Using the Fisher's or Mann‐Whitney method, regarding the mean transfusion of blood products and/or administration of hemostatic products, there was no significant difference between the two groups, both intraoperatively and within 24 hours postoperatively . Also, in the analysis of the percentage of patients who received transfusion of blood products and/or hemostatic products, there was no significant difference between the two groups, both intraoperatively and within 24 hours postoperatively. Using the Fisher's or Mann‐Whitney method, we did not observe any statistical difference related to postoperative complications, such as pulmonary infection, acute rejection, hepatic artery thrombosis, sepsis, reoperation within 24 hours of the postoperative period and acute renal failure in both groups. We did not find a significant difference in the other EXTEM or FIBTEM analyses using the Two‐way ANOVA method or Bonferroni posttests. ;
Epistemonikos ID: fcfe5e7c7524ec53a7861d475a2580b306821160
First added on: Feb 20, 2024