Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

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

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

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Cleft Palate
• Intervention / Treatment: Drug: Saline; Drug: Tranexamic Acid

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline infusion: Group receiving saline as placebo during the surgical procedure	Drug: Saline; Infusion of saline in the same rate used for the intervention group; Other Names: Control
Experimental: 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.	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; Other Names: Transamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	1 month
incidence of significant bleeding complications	Incidence of bleeding requiring surgical intervention, blood transfusion or use of antifibrinolytic drugs in the postoperative period	During hospital stay, an expected average of 2 days

Collaborators and Investigators

• Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Investigators: Principal Investigator: Guilherme C Arantes, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 21, 2015

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Hemorrhage; Cleft Palate; Palatoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Intraoperative Complications; Hemorrhage; Cleft Palate; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: U1111-1167-4683