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Clinical Trials/EUCTR2006-001299-19-GB
EUCTR2006-001299-19-GB
Active, not recruiting
Phase 1

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

Golden Jubilee National Hospital0 sites132 target enrollmentApril 13, 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Golden Jubilee National Hospital
Enrollment
132
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 13, 2006
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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