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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 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 420 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05523297
The ClinicalTrials.gov registry entry for NCT05523297 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Octaplex is the first listed.
NCT05523297 reports 0 study locations.
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.
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