Status:
COMPLETED
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Lead Sponsor:
Pfizer
Conditions:
Biliary Tract Surgical Procedures
Pancreaticoduodenectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 res...
Eligibility Criteria
Inclusion
- Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00827931
Start Date
September 1 2009
End Date
May 1 2011
Last Update
April 26 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Surat, Gujarat, India, 395 001
2
Pfizer Investigational Site
Vadodara, Gujarat, India, 390 001