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NCT05523297 · ClinicalTrials.gov registry record · Phase 3
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
A Phase 3 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
NCT05523297: Completed Phase 3 study, sponsored by Octapharma.
NCT05523297 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 420 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05523297, a Phase 3 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
Study Summary
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
Primary Outcome
Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII \[rFVIIa\], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP.
Interventions
- DRUG Octaplex
- DRUG Frozen Plasma Product, Human
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2024-06-27 |
| Phase | Phase 3 |
What the finished NCT05523297 record still lists
NCT05523297 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Octaplex is the first listed.
NCT05523297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05523297 about?
NCT05523297 is a clinical study titled "Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery". This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
What is the current status of trial NCT05523297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2022-11-30. Estimated completion is 2024-06-27.
What interventions are being tested in trial NCT05523297?
The interventions under investigation include: Octaplex (DRUG), Frozen Plasma Product, Human (DRUG).
Who is sponsoring clinical trial NCT05523297?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05523297's enrollment target sits among peer trials
420 891st of 2000 higher than 1,102 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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