The effect tranexamic acid on hemorrhage in cleft palate reconstraction surgery
Phase 4
- Conditions
- cleft palate with or without cleft lip.Cleft palate, Cleft palate with cleft lipQ35,Q37
- Registration Number
- IRCT2015112325208N1
- Lead Sponsor
- Vice Chancellor for research of Zahedan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Inclusion Criteria: Palatoplasty indication in patients with presence of congenital cleft palate (with or without associated cleft lip).
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;
History of hematuria.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraoperative bleeding. Timepoint: during surgery. Method of measurement: Intraoperative bleeding volume defined as the sum of the volume blood in the suction during the procedure and the volume of blood retained in the used gauze.;Operative duration. Timepoint: since anesthesia induction until patient exited from operation room. Method of measurement: Data collection form.
- Secondary Outcome Measures
Name Time Method Hemoglobin(Hb). Timepoint: 6 hour after procedure. Method of measurement: Data collection form.;Bleeding requiring reoperative homeostasis. Timepoint: post operation. Method of measurement: Data collection form.