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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Femoral Fractures

Intervention / Treatment
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* Drug: Tranexamic Acid plus standard of care
* Procedure: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Tranexamic Acid plus standard of care | Drug: Tranexamic Acid plus standard of care<br>* 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)<br>|
| Other: B<br>Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss. | Procedure: Standard of care<br>* Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Blood Loss | Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | Baseline through Day 7 post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative Blood Loss | Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | Day 1 (End of surgery) | 
| Post-operative Blood Loss | Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | 1, 4, 8 and 24 hours post-surgery | 
| Total Blood Loss Assessed by Gross' Formula | Gross's formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg. | Day 7 post-surgery | 
| Number of Participants Receiving Transfusions | A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent. | Up to day 7 post-surgery | 
| Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery |  | Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery | 
| Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth. | Day 5 post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic Acid, Blood Loss, Long Bone Fracture Surgery