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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-06-30

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.

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Detailed Description

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Conditions

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Femoral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Tranexamic Acid plus standard of care

Group Type EXPERIMENTAL

Tranexamic Acid plus standard of care

Intervention Type DRUG

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.

Group Type OTHER

Standard of care

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type DRUG

Standard of care

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No