Status:
COMPLETED
Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery
Lead Sponsor:
University Health Network, Toronto
Conditions:
Spine Surgery
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Spinal fusion surgery can be associated with significant blood loss requiring allogeneic blood transfusion. Tranexamic acid is a synthetic amino acid with antifibrinolytic action that has been shown t...
Detailed Description
Spinal fusion can be associated with significant blood loss requiring allogeneic blood transfusion (ABT). Ongoing concerns about the costs, risks, and availability of allogeneic blood have prompted th...
Eligibility Criteria
Inclusion
- All adult patients (greater than 18 years old) undergoing elective posterior thoracic/lumbar instrumented spinal fusion.
Exclusion
- Participation in another clinical trial
- Allergy to TA
- Spinal tumor/Intradural pathology
- Ankylosing spondylitis
- Acquired disturbances of color vision
- Preoperative anemia (Hb \<110 in females, Hb \<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
- Hematological disease (thromboembolic events, hemoglobinopathy, coagulopathy or hemolytic disease)
- Preoperative platelet count \<150,000/cubic mm, INR\>1.4, prolonged PTT
- Significant co-morbidities: Previous MI ; severe ischemic heart disease (NYHA Class III, IV) ; severe pulmonary disease ; chronic renal failure ; hepatic failure ; uncontrolled hypertension
- Pregnancy or lactation
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00444470
Start Date
February 1 2003
End Date
May 1 2007
Last Update
November 30 2007
Active Locations (3)
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1
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
3
Department of Anesthesia and Orthopedics; Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8