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NCT Number: NCT00824564

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

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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Key information

Conditions

Femoral Fractures Fractures, Bone Hemorrhage Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Coimbatore, Tamil Nadu, 641009, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid plus standard of care

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)

Standard of care

Procedure

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

Primary outcomes

  1. Total Blood Loss

    Time frame: 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 outcomes

  1. Intra-operative Blood Loss

    Time frame: 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.

  2. Post-operative Blood Loss

    Time frame: 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.

  3. Total Blood Loss Assessed by Gross' Formula

    Time frame: 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.

  4. Number of Participants Receiving Transfusions

    Time frame: 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.

  5. 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

    Time frame: Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery

  6. Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 16, 2009
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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