Prospective randomised trial comparing intraoperative topical Quixil and intravenous tranexamic acid in reduction of blood loss following primary hip and knee joint replacement surgery - Tranexamic acid vs. Quixil - reducing blood loss in joint replacement

Phase 1

• Conditions: Elective total knee replacement and total hip replacement.

• Registration Number: EUCTR2006-001299-19-GB
• Lead Sponsor: Golden Jubilee National Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 132

Inclusion Criteria

Patients who will be having primary cemented total hip or knee joint replacement during the period of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Uncemented arthroplasty.
2. Revision arthroplasty.
3. Patients on anticoagulant (warfarin, low molecular weight heparin) or other medication known to affect clotting (except aspirin, which is to be given as part of standard DVT prophylaxis in all cases).
4. Other drugs that may affect the activity of the drugs under investigation.
5. Allergy to asprin (all patients to receive 150mg aspirin as standard DVT prophylaxis for 6 weeks).
6. Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
7. Previous reaction or ethical/religious objection to receiving blood products (Quixil contains a derivative of human blood).
8. Pregnancy or breastfeeding.

Study & Design

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