drugset / Trial / NCT04785651
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies
RandomizedParallel-groupTriple-blindTreatment
Summary
A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies. All the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery
Timeline
- Start
- 2021-02-22
- Primary completion
- 2025-05-09
- Completion
- 2025-05-09
Outcome
Outcome not reported
Stopped (Enrollment): “Patient enrollment was proceeding slower than planned”
Publications
- Background Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.
- Background Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.
- Background Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 20 mg/kg | Intravenous |