Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

NCT ID: NCT02422056

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Cleft Palate; Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Saline infusion: Group receiving saline as placebo during the surgical procedure

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Intervention

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Other Intervention Names

Transamin; Control

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Campelo Arantes

Guilherme Campelo Arantes MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guilherme C Arantes

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Other Identifiers

U1111-1167-4683

Identifier Type: -

Identifier Source: org_study_id