Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422056
• Other study ID #: U1111-1167-4683
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: April 20, 2015
• Start date: December 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Cleft Palate
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes