Trial · NCT07881393
Prothrombin Complex Concentrate (PCC)
NCT07881393, Phase 4, Not yet recruiting, University of Miami
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prothrombin Complex Concentrate (PCC). Trials, record NCT07881393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07881393
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prothrombin Complex Concentrate (PCC)
- NCT number
- NCT07881393
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 70 participants, estimated
- Lead sponsor
- University of Miami
- Conditions
- Cardiopulmonary Bypass
- Interventions
- Four Factor Prothrombin Complex Concentrate, ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH)
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total 24-Hour Chest Tube Drainage Volume (mL) | From surgical closure through 24 hours postoperatively | Total volume of chest tube drainage, measured in milliliters (mL), collected from surgical closure through 24 hours postoperatively. A between-group reduction of 400 mL is considered clinically meaningful. |
| Secondary | Participants With Unplanned Return to the Operating Room Within 24 Hours | Within 24 hours after completion of the index surgical procedure | Number of participants requiring an unplanned return to the operating room for re-exploration due to hemorrhage or cardiac tamponade within 24 hours of the index surgical procedure. |
| Secondary | Total 4F-PCC Dose Administered (IU) | From the start of the index surgical procedure through 24 hours postoperatively | Total dose of 4-factor prothrombin complex concentrate (4F-PCC), measured in international units (IU), administered from the start of the index surgical procedure through the first 24 postoperative hours. Includes all intraoperative and postoperative 4F-PCC administration during the assessment period. |
| Secondary | Number of Units of packed red blood cells (pRBC) transfused | From the start of the index surgical procedure through 24 hours postoperatively | Total number of packed red blood cell units transfused per participant during the perioperative period. Transfusion data will be obtained from the electronic medical record and blood bank records. |
| Secondary | Number of Units of Fresh Frozen Plasma Transfused | From the start of the index surgical procedure through 24 hours postoperatively | Total number of fresh frozen plasma units transfused per participant. Transfusion data will be obtained from the electronic medical record and blood bank records. |
| Secondary | Number of Platelet Units Transfused | From the start of the index surgical procedure through 24 hours postoperatively | Total number of platelet units transfused per participant. Transfusion data will be obtained from the electronic medical record and blood bank records. |
| Secondary | Number of Cryoprecipitate Units Transfused | From the start of the index surgical procedure through 24 hours postoperatively | Total number of cryoprecipitate units transfused per participant. Transfusion data will be obtained from the electronic medical record and blood bank records. |
| Secondary | Duration of mechanical ventilation (hours) | From endotracheal intubation until successful extubation, up to 30 days postoperatively | Total duration of invasive mechanical ventilation, measured as the number of hours from endotracheal intubation until successful extubation. Data will be obtained from ventilator records and the electronic medical record. |
| Secondary | Intensive Care Unit Length of Stay length of stay (Days) | From ICU admission through ICU discharge, up to 30 days postoperatively | Total length of stay in the intensive care unit, measured as the number of days from ICU admission to ICU discharge. Data will be obtained from the electronic medical record. |
| Secondary | 30-day all-cause mortality | 30 days following the index surgical procedure | The number of participants who die from any cause within 30 days following the index surgical procedure. Mortality status will be determined from the electronic medical record and follow-up assessment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07881393
GET https://conductscience.org/api/trials/v1/NCT07881393/registered