Influence of tranexamic acid on blood loss in total joint replacement
Research type
Research Study
Full title
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 arthroplasty.
IRAS ID
188059
Contact name
David Beverland
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Eudract number
2015-002661-36
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Although numerous studies have demonstrated efficacy in using tranexamic acid in primary hip and knee replacements, it has not yet become a recognised standard of care in the UK. In part this is because of concerns about safety. This has meant that many trials to date have excluded patients who could most benefit from a reduced peri-operative blood loss such as patients with a history of ischaemic heart disease. Also and despite any published evidence, there have been concerns about a potential increased risk of venous thrombo-embolism which in itself has been a contentious issue in the UK. In Musgrave Park Hospital at present tranexamic acid is used sporadically by some surgeons and in patients known to have a high risk of bleeding such as patients with haemophilia and rapidly progressive osteoarthritis of the hip. A neglected area of clinical study into tranexamic acid is the most effective duration of treatment peri-operatively. There is little published work into treatment regimes that extend beyond an intravenous dose at 3 hours post-operatively. Evidence from our own practice suggests the potential for tranexamic acid to further reduce blood loss by continuing it to 24 hours post-operatively.
The primary objective of this study is 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 dose alone for patients undergoing unilateral primary total hip or knee replacement. This trial will also contribute to literature for resolving the question of whether or not tranexamic acid increases the risk of perioperative venous and arterial thrombo-embolism. Finally it will influence whether or not perioperative tranexamic acid becomes a standard of care in both Musgrave Park Hospital and elsewhere.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0068
Date of REC Opinion
10 Mar 2016
REC opinion
Further Information Favourable Opinion