NCT03690037: TRAC-24

Investigating the Effect of Intravenous and Oral Tranexamic Acid on Blood Loss After Primary Hip and Knee Arthroplasty

Completed Phase 4 Last updated 15 April 2022

What this trial tests

Phase 4 trial testing Tranexamic Acid 100 MG/ML in Primary Total Knee Arthroplasty in 1,089 participants. Completed in 8 July 2019.

Timeline

7 July 2016

Primary endpoint
8 July 2018

8 July 2019

Quick facts

Lead sponsor	Belfast Health and Social Care Trust
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,089
Start date	7 July 2016
Primary completion	8 July 2018
Estimated completion	8 July 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Tranexamic Acid 100 MG/ML — full drug profile →
• Tranexamic Acid 500 MG — full drug profile →

Conditions studied

• Primary Total Knee Arthroplasty — all drugs for Primary Total Knee Arthroplasty →
• Primary Total Hip Arthroplasty — all drugs for Primary Total Hip Arthroplasty →

Sponsor

Belfast Health and Social Care Trust — full company profile →

Who can join

Adults 18 to 100, any sex, with Primary Total Knee Arthroplasty or Primary Total Hip Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients having a hip or knee replacement can lose almost a third of their blood during and after the operation. Many patients, especially those who are older will need a blood transfusion, suffer from anaemia, or have a slow recovery after the operation. Tranexamic acid is a medication used to treat or prevent excessive blood loss, but in joint replacements, is only used in patients who are likely to bleed a lot. This trial aims to find out how well tranexamic acid works to reduce blood loss after the operation in a large group of patients having a hip or knee replacement, including those at risk of blood clots. This study also aims to find out how safe tranexamic acid treatment is to use in different patients and the best way to give tranexamic acid (in tablet form or through a drip), as well as how much to give and how long it should be given after an operation. All adults awaiting non-emergency hip or knee replacement surgery will be considered.

Patients who are suitable and agree to take part are randomly placed in one of two treatment groups: receiving tranexamic acid during the hip or knee operation through a drip, or receiving treatment during the hip or knee operation through a drip plus taking a tablet every 8 hours up to 24 hours after the operation. Initially, a no treatment group was included, however, one year after the trial started, the Data Monitoring and Ethics Committee who check safety, advised to stop allocation of patients to the no treatment group.

For all patients, blood loss is recorded up to 48 hours after surgery. Blood samples are also taken in order to measure how well the heart and blood clotting systems are working. If the routine kidney function tests taken before the operation show less than normal function, a lower dose of tranexamic acid is used.

It is expected that patients who receive the tranexamic acid will lose much less blood during and after their operation, and so be less likely to need a blood transfusion, have reduced stress on the heart and have an easier recovery. It is thought that patients with a history of clots are more likely to have another clot when taking tranexamic acid. Therefore, this trial will include these patients to try and find out if this is true as these patients will benefit the most from reduced blood loss.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacological interventions for the prevention of bleeding in people undergoing elective hip or knee surgery: a systematic review and network meta-analysis.
   Gibbs VN, Champaneria R, Sandercock J, Welton NJ, et al · · 2024 · cited 19× · PMID 38226724 · DOI 10.1002/14651858.cd013295.pub2
2. Using tranexamic acid for an additional 24 hours postoperatively in hip and knee arthroplasty saves money: a cost analysis from the TRAC-24 randomized control trial.
   Karayiannis PN, Agus A, Bryce L, Hill JC, et al · · 2022 · cited 2× · PMID 35816170 · DOI 10.1302/2633-1462.37.bjo-2021-0213.r1