Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 to reduce perioperative blood loss in patients undergoing cardiopulmonary bypass for cardiac bypass surgery, knee replacement and liver transplantation surgeries. The efficacy of antifibrinolytics for reduction of blood loss in major spine surgery has not been well studied in adult patients. The objective of this study is to determine the efficacy of tranexamic acid in reducing perioperative blood loss and blood transfusion in adults undergoing elective spinal fusion in a larger, multi-centered, randomized, double-blinded, placebo controlled trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• All adult patients (greater than 18 years old) undergoing elective posterior thoracic/lumbar instrumented spinal fusion.

Exclusion Criteria:

• 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