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

Femoral Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824564
• Other study ID #: B1461002
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2009
• Last updated: June 6, 2011
• Start date: April 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hemorrhage

Intervention

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)

Procedure:
• Standard of care
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Coimbatore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes

External Links

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