A Phase 4 interventional study of Four Factor Prothrombin Complex Concentrate and ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH) in Cardiopulmonary Bypass, sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
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.
University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.
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Participants receive 4-factor prothrombin complex concentrate (PCC; Kcentra) by intravenous infusion. Baseline and post-cardiopulmonary bypass ROTEM assessments are performed. Initial PCC dosing is determined using a prespecified ROTEM-guided algorithm based on clotting time (CT) prolongation relative to baseline, with dose categories ranging from 10 to 50 IU/kg. Subsequent dosing adjustments are guided by post-treatment ROTEM results using a sequential response-guided dosing strategy. Additional PCC may be administered at clinician discretion as clinically indicated.
Drug: Four Factor Prothrombin Complex Concentrate · Device: ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH)
Participants receive 4-factor prothrombin complex concentrate (PCC; Kcentra) by intravenous infusion. PCC dosing is determined by the attending cardiac anesthesiologist or cardiac surgeon based on clinical assessment and available laboratory results. No protocol-mandated ROTEM trigger or dosing algorithm is used. Additional PCC may be administered as clinically indicated according to standard practice
Drug: Four Factor Prothrombin Complex Concentrate
4-factor prothrombin complex concentrate (4F-PCC; Kcentra, CSL Behring) administered by intravenous infusion according to package insert instructions. Dosing is determined according to study arm assignment.
ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH), an FDA-cleared point-of-care coagulation monitoring device used to guide PCC dosing decisions.
Total 24-Hour Chest Tube Drainage Volume (mL)
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.
Time frame: From surgical closure through 24 hours postoperatively
Participants With Unplanned Return to the Operating Room Within 24 Hours
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.
Time frame: Within 24 hours after completion of the index surgical procedure
Total 4F-PCC Dose Administered (IU)
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.
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Units of packed red blood cells (pRBC) transfused
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.
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Units of Fresh Frozen Plasma Transfused
Total number of fresh frozen plasma units transfused per participant. Transfusion data will be obtained from the electronic medical record and blood bank records.
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Platelet Units Transfused
Total number of platelet units transfused per participant. Transfusion data will be obtained from the electronic medical record and blood bank records.
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Cryoprecipitate Units Transfused
Total number of cryoprecipitate units transfused per participant. Transfusion data will be obtained from the electronic medical record and blood bank records.
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Duration of mechanical ventilation (hours)
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.
Time frame: From endotracheal intubation until successful extubation, up to 30 days postoperatively
Intensive Care Unit Length of Stay length of stay (Days)
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.
Time frame: From ICU admission through ICU discharge, up to 30 days postoperatively
30-day all-cause mortality
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.
Time frame: 30 days following the index surgical procedure
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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