Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Professor Fernando Figueira Integral Medicine Institute

Status and phase: Completed; Phase 4

Conditions: Hemorrhage; Cleft Palate

Treatments: Drug: Saline; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02422056

U1111-1167-4683

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid