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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00824564 |
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.
Condition | Intervention | Phase |
---|---|---|
Femoral Fractures |
Drug: Tranexamic Acid plus standard of care Procedure: Standard of care |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture |
Estimated Enrollment: | 94 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Tranexamic Acid plus standard of care
|
Drug: Tranexamic Acid plus standard of care
Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
|
B
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.
|
Procedure: Standard of care
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
India, Tamil Nadu | |
Pfizer Investigational Site | Recruiting |
Coimbatore, Tamil Nadu, India, 641009 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | B1461002 |
Study First Received: | January 14, 2009 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00824564 History of Changes |
Health Authority: | India: Institutional Review Board |
Tranexamic Acid
Blood Loss
Long Bone Fracture Surgery |
Fibrin Modulating Agents Antiplasmin Femoral Fractures Antifibrinolytic Agents Fractures, Bone Wounds and Injuries |
Anesthetics Disorders of Environmental Origin Tranexamic Acid Leg Injuries Hemorrhage Hemostatics |
Molecular Mechanisms of Pharmacological Action Coagulants Fractures, Bone Hematologic Agents Wounds and Injuries Disorders of Environmental Origin Tranexamic Acid |
Pharmacologic Actions Hemostatics Femoral Fractures Fibrin Modulating Agents Antifibrinolytic Agents Therapeutic Uses Leg Injuries |