drugset / Trial / NCT02229292
Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid
Phase 4
Completed
104 enrolled
Esbjerg Hospital - University Hospital of Southern Denmark
University of Copenhagen · collabVestjydsk Ortopædisk Fond · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tranexamic Acid | Small molecule | 1 g | Intravenous |
Indications
No indication recorded.