At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 22 enrolled
Drug / intervention
Tranexamic acid +1 moredrug
Likely dose
Tranexamic acid 31 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study Comparing Anti-Inflammatory Effects Of Tranexamic Acid Versus Epsilon Aminocaproic Acid In Pediatric Congenital Heart Surgery
In Brief
A Phase 4 clinical trial evaluating Tranexamic acid and Epsilon Aminocaproic Acid for Pediatric Cardiac Surgery and Complication of Extracorporeal Circulation. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartFeb 2016
Primary CompletionApr 2017
TodayJul 2026
First PostedJan 15, 2016
Enrollment StartFeb 1, 2016
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.5 years ago
Interventions
Tranexamic aciddrug
TXA Loading dose: 31 mg/kg diluted to 2 ml/kg Normal saline (NS) -in syringe
Epsilon Aminocaproic Aciddrug
Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS