At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 62 enrolled
Drug / intervention
Fibrinogendrug
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.
The Use of Fibrinogen Concentrate in High-Risk Cardiac Surgery. A Prospective, Double-blinded, Randomized, Controlled Study
In Brief
A Phase 3 clinical trial evaluating Fibrinogen for Cardiac Complication During Procedure. Completed, enrolled 62 participants across 1 site.
Detailed Summary
The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Complication During Procedure
CountriesCanada
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartFeb 2014
Primary CompletionMar 2019
Study CompletionJun 2019
TodayJul 2026
First PostedJun 20, 2012
Enrollment StartFeb 1, 2014
Primary CompletionMar 31, 2019
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.0 years ago
Interventions
Fibrinogendrug
Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)