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

Phase 4

Completed

Conditions: Femoral Fractures

Interventions: Drug: Tranexamic Acid plus standard of care
Procedure: Standard of care

Registration Number: NCT00824564

Lead Sponsor: Pfizer

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, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tranexamic Acid plus standard of care	Tranexamic Acid plus standard of care
B	Standard of care	Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.

Primary Outcome Measures

Name	Time	Method
Total Blood Loss	Baseline through Day 7 post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Intra-operative Blood Loss	Day 1 (End of surgery)	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.
Post-operative Blood Loss	1, 4, 8 and 24 hours post-surgery	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.
Total Blood Loss Assessed by Gross' Formula	Day 7 post-surgery	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.
Number of Participants Receiving Transfusions	Up to day 7 post-surgery	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.
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	Day 5 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.