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Clinical Trial Summary

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


Clinical Trial Description

Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10mg / kg bolus followed by continuous infusion of 1 mg / kg / h until the end of the procedure and patients receiving placebo in similar arrangements.

Besides the impact on the volume of intraoperative bleeding the incidence of postoperative wound dehiscence in the first week and the incidence of oronasal fistulas after 1 month were evaluated. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02422056
Study type Interventional
Source Professor Fernando Figueira Integral Medicine Institute
Contact
Status Completed
Phase Phase 4
Start date December 2013
Completion date March 2015

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