drugset / Trial / NCT02229292

Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid

NCT02229292

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Purpose of the study: * To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery * To evaluate the potential effect of TXA on fibrin structure * To evaluate the potential effect of TXA of binding of plasminogen to fibrin * To evaluate the potential effect of TXA on postoperative edema formation. Hypothesis: H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid

Timeline

Start
2014-08-19
Primary completion
2016-09-26
Completion
2016-09-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 1 g Intravenous

Indications

No indication recorded.