Back to resultsAcid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty
Primary Purpose
Cleft Palate, Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Palate focused on measuring Cleft Palate, Hemorrhage, Palatoplasty
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Intervention
Arm Description
Saline infusion: Group receiving saline as placebo during the surgical procedure
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Oronasal fistulas
Presence of oronasal fistula type II, III or IV in pittsburgh classification verified on postoperative return at 1 month and photographic record.
incidence of significant bleeding complications
Incidence of bleeding requiring surgical intervention, blood transfusion or use of antifibrinolytic drugs in the postoperative period
Full Information
NCT ID
NCT02422056
First Posted
March 31, 2015
Last Updated
April 20, 2015
Sponsor
Professor Fernando Figueira Integral Medicine Institute
1. Study Identification
Unique Protocol Identification Number
NCT02422056
Brief Title
Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty
Official Title
Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty : Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Professor Fernando Figueira Integral Medicine Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate, Hemorrhage
Keywords
Cleft Palate, Hemorrhage, Palatoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline infusion: Group receiving saline as placebo during the surgical procedure
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Transamin
Intervention Description
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
Intervention Name(s)
Saline
Other Intervention Name(s)
Control
Intervention Description
Infusion of saline in the same rate used for the intervention group
Primary Outcome Measure Information:
Title
intraoperative bleeding
Description
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.
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Incidence of wound dehiscence
Description
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).
Time Frame
5 days
Title
Oronasal fistulas
Description
Presence of oronasal fistula type II, III or IV in pittsburgh classification verified on postoperative return at 1 month and photographic record.
Time Frame
1 month
Title
incidence of significant bleeding complications
Description
Incidence of bleeding requiring surgical intervention, blood transfusion or use of antifibrinolytic drugs in the postoperative period
Time Frame
During hospital stay, an expected average of 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilherme C Arantes
Organizational Affiliation
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty
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