Status:
COMPLETED
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Lead Sponsor:
Pfizer
Conditions:
Femoral Fractures
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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,...
Eligibility Criteria
Inclusion
- Patient undergoing surgery for fracture shaft of femur
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00824564
Start Date
April 1 2009
End Date
June 1 2010
Last Update
June 28 2011
Active Locations (1)
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1
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India, 641009