Elective total knee replacement and total hip replacement.
Conditions
Interventions
Product Name: Quixil
Product Code: Quixil
Pharmaceutical Form: Sealant
Other descriptive name: Human Clottable protein
Concentration uni
Sponsors
Golden Jubilee National Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: None.;Primary end point(s): End point will be total blood loss from operatation.; Main Objective: To compare the benefits of Quixil vs. Tranexamic acid in reducing blood loss in primary total hip replacement, and primary total knee replacement. Both medicines are used for the reduction of blood loss in major joint surgery; previous studies have shown each one to be effective and safe, but they have not been directly compared in this setting. | — |
Countries
United Kingdom
Outcome results
None listed