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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00827931
First received: January 22, 2009
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Biliary Tract Surgical Procedures
Pancreaticoduodenectomy
Esophagectomy
Colectomy
Gastrectomy
Drug: Tranexamic acid + 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 Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Post-operative Blood Loss [ Time Frame: Post-operation, Day 1, Day 2 up to drain removal ] [ 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.


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.

  • Total Blood Loss [ Time Frame: Baseline through Day 2 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.

  • Total Blood Loss as Assessed by the Gross' Formula [ Time Frame: Baseline through Day 2 post-surgery ] [ Designated as safety issue: No ]
    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 ] [ 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 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery [ Time Frame: Day 7 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: 94
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
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)
B
Standard of Care
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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00827931

Locations
India
Pfizer Investigational Site
Baroda, Gujarat, India, 390 001
Pfizer Investigational Site
Surat, Gujarat, India, 395 001
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00827931     History of Changes
Other Study ID Numbers: B1461001
Study First Received: January 22, 2009
Results First Received: April 2, 2012
Last Updated: April 2, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
tranexamic acid
major abdominal surgery
blood loss

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014