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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00824564
First received: January 14, 2009
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Femoral Fractures
Drug: Tranexamic Acid plus standard of care
Procedure: Standard of care
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Total Blood Loss [ Time Frame: Baseline through Day 7 post-surgery ] [ Designated as safety issue: No ]
    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:
  • Intra-operative Blood Loss [ Time Frame: Day 1 (End of surgery) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1, 4, 8 and 24 hours post-surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 7 post-surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to day 7 post-surgery ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery [ Time Frame: Day 5 post-surgery ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 82
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Tranexamic Acid plus standard of care
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)
B
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824564

Locations
India
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India, 641009
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00824564     History of Changes
Other Study ID Numbers: B1461002
Study First Received: January 14, 2009
Results First Received: June 6, 2011
Last Updated: June 6, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
Tranexamic Acid
Blood Loss
Long Bone Fracture Surgery

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Hemorrhage
Leg Injuries
Pathologic Processes
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014