Influence of tranexamic acid on blood loss for total joint replacement

Phase 1

• Conditions: Osteoarthritic patients who require hip or knee arthroplasty; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-002661-36-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-04
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1166

Inclusion Criteria

1. Patients awaiting primary elective hip or knee replacement in the Primary Joint Unit at Musgrave Park Hospital.
2. Patients greater than or equal to 18 years of age.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 583
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 583

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.Anticoagulant use within 7 days of surgery (thienopyridines, clopidogrel etc.*
12.Direct thrombin inhibitors within 2 days of surgery*
13.Xa inhibitors within 2 weeks of surgery*
14.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 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified