Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital

Exclusion Criteria:

• Preoperative hemoglobin lower than 10 mg / dl or platelet count less than 100,000 / mm3 ;

• Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;

• History of bleeding disorders in first-degree relatives;

• Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);

• Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;

• Known allergy to tranexamic acid.