At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 420 enrolled
Drug / intervention
Octaplex +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.
Prospective, Multicenter, Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Bleeding Adult Cardiac Surgical Patients
In Brief
A Phase 3 clinical trial evaluating Octaplex and Frozen Plasma Product, Human for Bleeding Cardiac Surgery Patients. Completed, enrolled 420 participants across 13 sites in 2 countries.
Detailed Summary
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding Cardiac Surgery Patients
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartNov 2022
Primary CompletionJun 2024
TodayJul 2026
First PostedAug 31, 2022
Enrollment StartNov 30, 2022
Primary CompletionJun 27, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.8 years ago
Interventions
Octaplexdrug
Prothrombin complex concentrate
Frozen Plasma Product, Humandrug
If additional treatment is required after the maximum dose of IMP is administered or the treatment period has elapsed, patients in both groups will receive frozen plasma