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

• Status: Completed
• Trial end date: 2019-07-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belfast Health and Social Care Trust
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Awaiting primary elective hip or knee replacement

2. ≥ 18 years of age and ≤100 years

Exclusion Criteria:

1. Patients who do not pass a pre-operative assessment for elective total hip or knee arthroplasty (THA/TKA)

2. Fractured neck of femur

3. Haemophiliac or coagulation disorders that require TXA

4. Allergy to tranexamic acid or any of its excipients

5. Platelets less than 75,000/mm3 at pre-operative assessment*

6. Patients on active treatment for venous thromboembolism (VTE) (deep vein thrombosis (DVT), pulmonary embolisms (PE)) within 6 months of surgery*

7. History of VTE within 6 months of surgery*

8. Patients who have had a myocardial infarction (MI) within 12 months*

9. Cardiac stent within 12 months of surgery*

10. Patients who have had a stroke (cerebrovascular accident (CVA)) or transient ischemic attack (TIA) within 9 months of surgery*

11. Use of antiplatelet medication within 7 days of surgery* (Does not include aspirin if dose <300mg).

12. Direct thrombin inhibitors within 2 days of surgery*

13. Factor Xa inhibitors within 2 days of surgery*

14. The International normalized ratio (INR) level is greater than or equal to 1.5 in a patient who has stopped warfarin in preparation for surgery

15. Hepatic failure*

16. Patients with epilepsy

17. Patients requiring therapeutic anticoagulation post-operatively e.g. Metallic heart valves.

18. Pregnant women, women who have not yet reached the menopause (no menses for ≥ 12 months without an alternative medical cause) who test positive for pregnancy or are unwilling to take a pregnancy test prior to trial entry

19. Patients who have been using Combined hormonal contraception (which includes combined oral contraception (COC), combined contraceptive transdermal patch and vaginal ring) within 4 weeks of surgery*.

20. Female patients who are breastfeeding

21. Treated with any other investigational medication or device within 60 days

22. Patients unable to provide informed consent

23. Patients who are unable or unwilling to commit to the study schedule of events

24. Patients unwilling to provide informed consent

25. Patients who present for simultaneous bilateral THA or TKA

26. Patients who are on renal dialysis and have an arteriovenous (AV) fistula

27. Patients who previously have been enrolled in this study

• These are patients with contra-indications to primary hip or knee replacement.