Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Phase 4

Completed

• Conditions: Hemorrhage; Cleft Palate
• Interventions: Drug: Saline; Drug: Tranexamic Acid

• Registration Number: NCT02422056
• Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute

Brief 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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Study First Submitted: 2015-03-31
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-20
• Last Update Submitted: 2015-04-20
• Study First Posted: 2015-04-21
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline infusion: Group receiving saline as placebo during the surgical procedure
Intervention	Tranexamic Acid	Tranexamic acid infusion: Group that received a Tranexamic acid bolus of 10mg / kg, followed by continuous infusion of 1 mg / kg / hr until the end of the procedure.

Primary Outcome Measures

Name	Time	Method
intraoperative bleeding	during surgery	Intraoperative bleeding volume defined as the sum of the volume of aspirated blood during the procedure and the volume of blood retained in the used gauze. The volume retained in the gauze was estimated by the difference between the dry weight and the weight after using them.

Secondary Outcome Measures

Name	Time	Method
incidence of significant bleeding complications	During hospital stay, an expected average of 2 days	Incidence of bleeding requiring surgical intervention, blood transfusion or use of antifibrinolytic drugs in the postoperative period
Incidence of wound dehiscence	5 days	Presence of dehiscence of the surgical wound in partial or total plan of any extension, verified by clinical examination in the first postoperative return and photographic record. The existence of dehiscence was observed by the break in the suture line or extensive presence of fibrin in the wound bed (indicating open area at its base).
Oronasal fistulas	1 month	Presence of oronasal fistula type II, III or IV in pittsburgh classification verified on postoperative return at 1 month and photographic record.