drugset / Trial / NCT04360629

Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer

NCT04360629 ↗

Completed 151 enrolled Jun Zhang
RandomizedParallel-groupSingle-blindOther

Summary

Tranexamic acid has been used in surgery for more than 30 years. It's effect on reducing bleeding and blood transfusing has been demonstrated. In our hospital, the amount of cytorsductive surgery for ovarian cancer is big. During the perioperation , bleeding probability is high, and the supply of blood products is limited. In order to reduce bleeding, we're planning to use tranexamic acid in the operations. In this experiment, we will observe the efficacy of tranexamic acid in cytoreductive surgery for ovarian cancer, find the best dosage which can reach the desired effect, and the possible side-effect.

Timeline

Start
2020-06-03
Primary completion
2021-12-30
Completion
2021-12-30

Outcome

Mixed primary results

paper The primary endpoint was intraoperative blood loss volume and total blood loss volume PMID 37029431 ↗

paper The patients in the high-dose group had less intraoperative (median [IQR]: 625.3 mL [343.5-1210.5]) and total blood loss volume PMID 37029431 ↗

paper p = 0.012; and 1700.7 mL [458.7-2419.8], p = 0.004, respectively). PMID 37029431 ↗

paper the intraoperative (992.5 mL [539.0-1404.0], p = 0.874) and total blood loss volume (1025.0 mL [381.8-1819.9], p = 0.113) was not significantly reduced PMID 37029431 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1 mg/kg Intravenous
Subject Tranexamic Acid Small molecule 5 mg/kg Intravenous

Indications