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Trial record 1 of 1 for:    NCT00824564
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Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

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ClinicalTrials.gov Identifier: NCT00824564
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 14, 2009
First Posted Date  ICMJE January 16, 2009
Results First Submitted Date  ICMJE June 6, 2011
Results First Posted Date  ICMJE June 28, 2011
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
Total blood loss (intra-operative + post-operative) [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
  • Intra-operative Blood Loss [ Time Frame: 1 day ]
  • Postoperative blood loss [ Time Frame: 1, 4, 8, 24 hours ]
  • Total blood loss as assessed by Gross' formula [ Time Frame: 7 days ]
  • Proportion of patients receiving transfusions [ Time Frame: 7 days ]
  • Hemoglobin levels [ Time Frame: at the end of the operation, one hour postoperatively and on the mornings of the first, second, four ]
  • Incidence of deep vein thrombosis postoperatively [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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