Status:
COMPLETED
Topical Tranexamic Acid for Total Knee Arthroplasty
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Surgical Blood Loss
Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed...
Detailed Description
Three million (1 in 10) Canadians suffer from Osteoarthritis (OA). Total knee arthroplasty (TKA), i.e. knee replacement surgery is the definitive treatment for knee osteoarthritis which alleviates pai...
Eligibility Criteria
Inclusion
- All adult patients (greater than 18 years old).
- Patients scheduled for primary unilateral total knee arthroplasty.
Exclusion
- Allergy to tranexamic acid
- Acquired disturbances of color vision
- Preoperative anemia (hemoglobin \<110 in females; hemoglobin \<120 in males)
- Refusal of blood products (Jehovah's witnesses),
- Preoperative use of anticoagulant therapy - coumadin, heparin within 5 days of surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment,
- Coagulopathy (preoperative platelet count \< 150,000/mm3, INR \>1.4, prolonged PTT (\>1.4 x normal))
- A previous history of thromboembolic disease (e.g. CVA, DVT or PE)
- Pregnancy
- Breastfeeding
- Significant co-morbidities:
- severe ischemic heart disease; NYHA Class III, IV,
- previous myocardial infarction
- severe pulmonary disease, e.g. FEV1\<50% normal,
- plasma creatinine greater than 115 µmol/l in males and more than 100 µmol/l in females
- hepatic failure
- Intraoperative surgical/medical/anesthetic complications occur, e.g. MI, intraoperative bone fracture or neurovascular injury
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00985920
Start Date
September 1 2007
End Date
November 1 2009
Last Update
April 11 2011
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8