At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 50 enrolled
Drug / intervention
octaplasbiological
Likely dose
Not stated in 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.
An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors.
In Brief
A Phase 4 clinical trial evaluating octaplas for Liver Surgery and 3 related conditions. Completed, enrolled 50 participants across 4 sites.
Detailed Summary
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors. Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartDec 2014
Primary CompletionDec 2017
TodayJul 2026
First PostedJan 31, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 4, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.4 years ago
Interventions
octaplasbiological
Octaplas S/D Plasma