Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Anesthetics; Tranexamic Acid

Criteria

Inclusion Criteria:

• Patient undergoing surgery for fracture shaft of femur

Exclusion Criteria:

• Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia

• Patients with known coagulopathy

• Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%)

• Patients with documented DVT or PE at screening or in past three months

• Patients having known hypersensitivity to tranexamic acid or any other constituent of the product

• Patients with any associated major illness (e.g., severe cardiac or respiratory disease)

• Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week