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

Study Overview
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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.

Official Title
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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

Conditions
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Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy, Colectomy, Gastrectomy

Intervention / Treatment
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* Drug: Tranexamic acid + Standard of Care
* Procedure: Standard of Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>end of the operation and on the mornings of the first, second, fourth and seventh postoperative days. | Drug: Tranexamic acid + Standard of Care<br>* 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)<br>|
| Other: B<br>Standard of Care | Procedure: Standard of Care<br>* Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post-operation, Day 1, Day 2 up to drain removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to Day 7 post-surgery | 
| Hemoglobin Levels |  | 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. | Day 7 post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, major abdominal surgery, blood loss