| 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 | |
| Links | http://www.isrctn.com/ISRCTN58790500 |