Investigating the influence of intravenous and oral tranexamic acid on blood loss for patients undergoing primary hip and knee replacements

Phase 4

Completed

• Conditions: Elective primary hip or knee replacement; Musculoskeletal Diseases

• Registration Number: ISRCTN58790500
• Lead Sponsor: The Belfast and Health Social Care Trust (BHSCT)

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30064517 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34192922/ results for total hip arthroplasty (added 20/01/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34587808/ results for total knee arthroplasty (added 20/01/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35816170/ Cost analysis (added 10/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-21
• Study Completion: 2020-07-06
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1056

Inclusion Criteria

1. Awaiting primary elective hip or knee replacement
2. Both male & female
3. Aged between 18 and 100 years

Exclusion Criteria

Current participant exclusion criteria as of 28/03/2018:
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 <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).Anticoagulant use within 7 days of surgery (thienopyridines, clopidogrel etc.)*
12. Direct thrombin inhibitors within 2 days of surgery*
13. Factor Xa inhibitors within 2 days of surgery*Xa inhibitors within 2 weeks of surgery*
14. The INR level is greater than or equal to 1.5 in a patient who has stopped warfarin in preparation for surgery Patients who have stopped Warfarin in preparation for surgery but have an INR level greater than or equal to 1.5*
15. Hepatic failure*
16. Patients with epilepsy
17. Patients requiring therapeutic anticoagulation post-operatively eg. 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, 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*.Patients who have taken the combined oral contraceptive pill 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 AV fistula
27. Patients who previously have been enrolled in this study
*These are patients with contra-indications to primary hip or knee replacement.

Original participant 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/mm3at 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. Anticoagulant use within 7 days of surgery (thienopyridines, clopidogrel etc.)*
12. Direct thrombin inhibitors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Indirectly calculated blood loss (ml) 48 hours post-surgery is calculated by using red cell counts before and after surgery in a mathematical formula.

Secondary Outcome Measures

Name	Time	Method
1. Incidence of post-operative haemoglobin (Hb) levels falling below the transfusion trigger (irrespective of transfusion) prior to discharge is measured from routine blood testing on day of surgery (Day 0) and post-operative Days 1-4<br>2. Effect of body mass index (BMI), pre-operative measure taken from the Belfast Orthopaedic Information System (BOIS), on the volume of indirect blood loss at 48 hours (Day 2) post-operative is found using statistical analysis by the Trial Statistician<br>3. C-reactive protein level is measured through blood testing at baseline and 48 hours post-surgery<br>4. Creatinine level is measured through blood testing at baseline and 48 hours post-surgery<br>5. 90 day mortality is measured using the BOIS and death registry at 90 days post-surgery<br>6. One year mortality is measured using BOIS and death registry at 1 year post-surgery