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

Pfizer94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Biliary Tract Surgical Procedures Pancreaticoduodenectomy Esophagectomy Colectomy Gastrectomy

Interventions

Tranexamic acid + Standard of CareDRUG

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)

Standard of CarePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Post-operative Blood Loss

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.

Time frame: Post-operation, Day 1, Day 2 up to drain removal

Secondary Outcomes

Intra-operative Blood Loss

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.

Time frame: Day 1 (End of surgery)

Total Blood Loss

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.

Time frame: Baseline through Day 2 post-surgery

Total Blood Loss as Assessed by the Gross' Formula

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.

Time frame: Baseline through Day 2 post-surgery

Percentage of Participants Receiving Transfusions

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.

Time frame: Up to Day 7 post-surgery

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

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.

Time frame: Day 7 post-surgery