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Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Baroda, Gujarat, 390 001 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy, Colectomy, Gastrectomy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
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)

- 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

NCT00827931
Pfizer
Completed
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

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Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Biliary Tract Surgical Procedures
  • Pancreaticoduodenectomy
  • Esophagectomy
  • Colectomy
  • Gastrectomy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
May 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00827931
B1461001
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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