Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Phase 4CompletedNCT02422056

Professor Fernando Figueira Integral Medicine Institute66 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cleft Palate Hemorrhage

Interventions

Tranexamic AcidDRUG

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

SalineDRUG

Infusion of saline in the same rate used for the intervention group

Eligibility

Sex: ALLMin age: 6 Months

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

intraoperative bleeding

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.

Time frame: during surgery

Secondary Outcomes

Incidence of wound dehiscence

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).

Time frame: 5 days

Oronasal fistulas

Presence of oronasal fistula type II, III or IV in pittsburgh classification verified on postoperative return at 1 month and photographic record.

Time frame: 1 month

incidence of significant bleeding complications

Incidence of bleeding requiring surgical intervention, blood transfusion or use of antifibrinolytic drugs in the postoperative period

Time frame: During hospital stay, an expected average of 2 days

Data from ClinicalTrials.gov

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