Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT02422056
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT02422056
Study Brief:
Protocol Section:
NCT02422056