Study of Tranexamic Acid for Reducing Blood Requirement in Patients Undergoing Major Gastro-intestinal Surgery

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective of the study is to compare requirement of blood transfusion and mortality in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it.

Secondary objective is to; assess the re-bleeding events; need for surgical intervention; length of stay in Intensive care unit in between the two groups.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
• Collaborator: Pfizer
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

All patients undergoing major GI surgery that includes resection of:

• Esophagus

• Stomach

• Spleen

• Liver

• Pancreas

• Colon

Exclusion Criteria:

• Pre op HB less than 10mg/dl

• Pregnant or lactating women

• On anticoagulation therapy

• Patients with history of thromboembolism

• Patients with history of myocardial infarction or ischemic cerebrovascular accident

• Patient with end stage renal disease

• Patients with DNR status

• Patients with known bleeding abnormalities

• Emergency/unplanned surgeries

• Patients with known allergy/contraindications to Tranexamic acid

• Patients not capable of giving consent for medical reasons (psychiatric etc)\

• Patients not giving consent or opting to withdraw from the study