Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

NCT02422056 | Completed Phase 4

• 1 other identifier: U1111-1167-4683
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cleft Palate; Hemorrhage

Keywords

Cleft Palate; Hemorrhage; Palatoplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of wound dehiscence

  5 days

• Oronasal fistulas

  1 month

• incidence of significant bleeding complications

  During hospital stay, an expected average of 2 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Saline

Intervention

EXPERIMENTAL

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

Interventions

Tranexamic Acid 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

Also known as: Transamin

Intervention

Saline DRUG

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

Also known as: Control

Placebo

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital

You may not qualify if:

• 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.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

MeSH Terms

Conditions

Cleft Palate; Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Guilherme C Arantes

  Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guilherme Campelo Arantes MD

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 21, 2015
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04