TRAC-24 Trial

Trial Acronym TRAC-24
Clinical Area Elective hip /knee replacement
Description A single centre randomised controlled trial to assess the effect of the addition of twenty-four hours of oral tranexamic acid post-operatively to a single intra-operative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee replacement.
Status Analysis and Reporting
Date Opened to Recruitment 7th July 2016
Target Recruitment Initially 1166 patients. Following the Interim Analysis, randomisation to Control Group 3 was stopped and target recruitment changed to 1066. A minimum of 932 patients is required comprising of 466 Group 1 (233 knee, 233 hip) and 466 Group 2 (233 knee, 233 hip)
Recruitment to date As of 6th July 2018, recruitment to TRAC24 study was completed. Total of 1089 have been recruited to the TRAC24 study
Date Closed to Recruitment N/A
No. of Sites 1
Trial Design A Phase IV, single centred, open label, parallel group, randomised controlled trial.
Study Aim
Objective 1: To determine if the use of oral tranexamic acid post-operatively for up to 24h hours will confer a reduction in calculated blood loss at 48 hours beyond an intra-operative intravenous bolus alone for patients undergoing unilateral primary total hip or knee replacement
Objective 2: To determine if the addition of oral TXA post-operatively to an intra-operative intravenous bolus of TXA produces any change in other measurable parameters as compared to those observed either with an intra-operative intravenous bolus alone or no TXA for patients undergoing unilateral primary THA/TKA.
Chief Investigator Prof David Beverland
Sponsors Belfast Health and Social Care Trust
Funder Belfast Arthroplasty Research Trust (BART)
HSC Research & Development Division, Public Health Agency