IRCT2015112325208N1CompletedPhase 4
The effect of preoperative intravenous tranexamic acid on hemorrhage in patients who undergoing cleft palate reconstraction surgery
Vice Chancellor for research of Zahedan University of Medical Sciences0 sites60 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 1 year to 12 years (—)
- Sex
- All
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.
Investigators
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