NCT00827931

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Surgical Procedures
• Pancreaticoduodenectomy
• Esophagectomy
• Colectomy
• Gastrectomy

Interventions

Type	Name	Description
DRUG	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)
PROCEDURE	Standard of Care	Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2009-01-23
• Last updated: 2012-04-26
• Results posted: 2012-04-26

Locations

2 sites across 1 country: India