NCT02422056

Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty : Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Professor Fernando Figueira Integral Medicine Institute · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cleft Palate
• Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Tranexamic acid bolus of 10 mg / kg at the beginning of palatoplasty, followed by infusion of 1 mg / kg / h until the end of the procedure
DRUG	Saline	Infusion of saline in the same rate used for the intervention group

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2015-04-21
• Last updated: 2015-04-21