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Trial record 1 of 1 for:    NCT00827931
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Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT00827931
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : April 26, 2012
Last Update Posted : April 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 22, 2009
First Posted Date  ICMJE January 23, 2009
Results First Submitted Date  ICMJE April 2, 2012
Results First Posted Date  ICMJE April 26, 2012
Last Update Posted Date April 26, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
Post-operative Blood Loss [ Time Frame: Post-operation, Day 1, Day 2 up to drain removal ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
To evaluate the efficacy of tranexamic acid plus standard of care compared to standard of care on the reduction in postoperative blood loss [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
  • 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.
  • Total Blood Loss [ Time Frame: Baseline through Day 2 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.
  • Total Blood Loss as Assessed by the Gross' Formula [ Time Frame: Baseline through Day 2 post-surgery ]
    Gross' formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.
  • Percentage 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 hematocrit value of 24 percent.
  • Hemoglobin Levels [ Time Frame: End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery ]
  • Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery [ Time Frame: Day 7 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 22, 2009)
  • Intra-operative blood loss. [ Time Frame: 1 day ]
  • Total blood loss [ Time Frame: 7 days ]
  • Total blood loss as assessed by Gross' formula [ Time Frame: 7 days ]
  • Number of patients receiving transfusions [ Time Frame: 7 days ]
  • Post-operative hemoglobin levels [ Time Frame: end of the operation and on the mornings of the first, second, fourth and seventh postoperative days ]
  • Post-operative incidence of deep vein thrombosis [ 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 Major Abdominal Surgery
Official Title  ICMJE Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Brief Summary Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.
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
  • Biliary Tract Surgical Procedures
  • Pancreaticoduodenectomy
  • Esophagectomy
  • Colectomy
  • Gastrectomy
Intervention  ICMJE
  • Drug: Tranexamic acid + 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
    end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
    Intervention: Drug: Tranexamic acid + Standard of Care
  • B
    Standard of Care
    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: January 22, 2009)
94
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)

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)
  • Patients with documented DVT or PE at screening or in past three months.
  • 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 and older   (Adult, Older 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 NCT00827931
Other Study ID Numbers  ICMJE B1461001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2012

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