Prothrombin Complex Concentrate (PCC)
Public ClinicalTrials.gov record NCT07881393. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Rotational Thromboelastometry (ROTEM) Guided Versus Clinician-Directed Prothrombin Complex Concentrate (PCC) Administration for Post-Cardiopulmonary Bypass Coagulopathic Bleeding in High-Risk Cardiac Surgery: A Randomized Controlled Pilot Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The overall objective of this study is to determine whether ROTEM (rotational thromboelastometry) guided dosing of four-factor prothrombin complex concentrate (4F-PCC) results in superior perioperative bleeding control compared to clinician-directed. PCC administration in adult patients undergoing high-risk cardiac surgery with cardiopulmonary bypass (CPB) who develop post-CPB coagulopathic bleeding.
Study identification
- NCT ID
- NCT07881393
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Interventions
- Four Factor Prothrombin Complex Concentrate Drug
- ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH) Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2026 (Estimated)
- Primary completion
- Nov 2027 (Estimated)
- Completion
- Nov 2027 (Estimated)
- Last update posted
- Oct 19, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami Hospital | Miami | Florida | 33136 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07881393, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07881393 live on ClinicalTrials.gov.