At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 106 enrolled
Drug / intervention
Prothrombin complex concentrate (Human) +1 moredrug
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.
Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for Post-cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center.
In Brief
A Phase 4 clinical trial evaluating Prothrombin complex concentrate (Human) and Fresh frozen plasma (FFP) for Bleeding and 4 related conditions. Completed, enrolled 106 participants across 1 site.
Detailed Summary
This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates, Fresh Frozen Plasma
CountriesUnited States
CollaboratorsCSL Behring
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartAug 2016
Primary CompletionJun 2021
Study CompletionJan 2022
TodayJul 2026
First PostedSep 23, 2015
Enrollment StartAug 1, 2016
Primary CompletionJun 1, 2021
Study CompletionJan 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.8 years ago
Interventions
Prothrombin complex concentrate (Human)drug
PCC (Kcentra)
Fresh frozen plasma (FFP)biological
FFP