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

NCT00824564

Last updated date
Study Location
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641009, India
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Femoral Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patient undergoing surgery for fracture shaft of femur

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Femoral FracturesStudy Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
NCT00824564
  1. Coimbatore, Tamil Nadu
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Femoral Fractures
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Tranexamic Acid plus standard of care
    Intervention: Drug: Tranexamic Acid plus standard of care
  • B
    Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.
    Intervention: Procedure: Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2010)
82
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2009)
94
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00824564
Other Study ID Numbers  ICMJE B1461002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP