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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Biliary Tract Surgical Procedures Pancreaticoduodenectomy Esophagectomy Colectomy Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.

Group Type EXPERIMENTAL

Tranexamic acid + Standard of Care

Intervention Type DRUG

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

Group Type OTHER

Standard of Care

Intervention Type PROCEDURE

Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Interventions

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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)

Intervention Type DRUG

Standard of Care

Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No