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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Biliary Tract Surgical Procedures; Esophagectomy; Pancreaticoduodenectomy; Gastrectomy; Colectomy

Treatments: Drug: Tranexamic acid + Standard of Care; Procedure: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00827931

B1461001

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid + Standard of Care

B

Other group

Description:

Standard of Care

Treatment:

Procedure: Standard of Care