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

Phase 4

Completed

Conditions: Biliary Tract Surgical Procedures
Pancreaticoduodenectomy
Esophagectomy
Colectomy
Gastrectomy

Interventions: Drug: Tranexamic acid + Standard of Care
Procedure: Standard of Care

Registration Number: NCT00827931

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 94

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tranexamic acid + Standard of Care	end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
B	Standard of Care	Standard of Care

Primary Outcome Measures

Name	Time	Method
Post-operative Blood Loss	Post-operation, Day 1, Day 2 up to drain removal	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

Name	Time	Method
Intra-operative Blood Loss	Day 1 (End of surgery)	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	Baseline through Day 2 post-surgery	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	Baseline through Day 2 post-surgery	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	Up to Day 7 post-surgery	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	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	Day 7 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.