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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Femoral Fractures

Treatments

Procedure: Standard of care

Drug: Tranexamic Acid plus standard of care

Study type

Interventional

Funder types

Industry

Identifiers

NCT00824564

B1461002

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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