University of Miami Hospital
Not reportedMiami, Florida, 33136, United States
CLINICAL STUDY · NCT07881393
Prothrombin Complex Concentrate (PCC)
Not yet recruitingPhase 4Interventional
Sponsored by University of Miami
- Condition
- Cardiopulmonary Bypass
- Study locations
- 1 reported site
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
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.
Full 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
PARTICIPATION
Who may participate
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion criteria
Inclusion Criteria:
* Age \>= 18 years
* Undergoing high-risk cardiac surgery with cardiopulmonary bypass, defined as any one or more of: (a) reoperation/redo cardiac surgery; (b) combined valve surgery and Coronary Artery Bypass Grafting (CABG); (c) aortic root or ascending aortic surgery; (d) surgery requiring hypothermic circulatory arrest; (e) active preoperative anticoagulation \[Vitamin K Antagonist (VKA), Direct Oral Anti-Coagulant (DOAC), or therapeutic heparin/ Low Molecular Weight Heparin (LMWH)\] within 5 days of surgery
* Clinically significant post-cardio pulmonary bypass (CPB) coagulopathic bleeding requiring coagulation factor replacement, as determined by the attending clinician, within 2 hours of CPB termination
* Attending clinician decision to administer Four Factor Prothrombin Complex Concentrate (4F-PCC) intraoperatively
* Written informed consent obtained preoperatively (or Legally Authorized Representative (LAR) consent; see Consent section for emergency waiver provisions)
Exclusion Criteria:
* Known hypersensitivity to Prothrombin Complex Concentrate (PCC), heparin, or any component of the 4F-PCC formulation
* Documented history of heparin-induced thrombocytopenia (HIT)
* Active thromboembolic event \[Deep Venous Thrombosis (DVT), Pulmonary Embolism (PE), acute ischemic stroke, or Myocardial Infarction (MI)\] within 3 months of surgery and not related to the index cardiac procedure
* Pregnancy
* Participation in another interventional clinical trial within 30 days
* Life expectancy less than 30 days from a non-cardiac cause
* Refusal of blood products precluding PCC administration
* Age \>= 18 years
* Undergoing high-risk cardiac surgery with cardiopulmonary bypass, defined as any one or more of: (a) reoperation/redo cardiac surgery; (b) combined valve surgery and Coronary Artery Bypass Grafting (CABG); (c) aortic root or ascending aortic surgery; (d) surgery requiring hypothermic circulatory arrest; (e) active preoperative anticoagulation \[Vitamin K Antagonist (VKA), Direct Oral Anti-Coagulant (DOAC), or therapeutic heparin/ Low Molecular Weight Heparin (LMWH)\] within 5 days of surgery
* Clinically significant post-cardio pulmonary bypass (CPB) coagulopathic bleeding requiring coagulation factor replacement, as determined by the attending clinician, within 2 hours of CPB termination
* Attending clinician decision to administer Four Factor Prothrombin Complex Concentrate (4F-PCC) intraoperatively
* Written informed consent obtained preoperatively (or Legally Authorized Representative (LAR) consent; see Consent section for emergency waiver provisions)
Exclusion Criteria:
* Known hypersensitivity to Prothrombin Complex Concentrate (PCC), heparin, or any component of the 4F-PCC formulation
* Documented history of heparin-induced thrombocytopenia (HIT)
* Active thromboembolic event \[Deep Venous Thrombosis (DVT), Pulmonary Embolism (PE), acute ischemic stroke, or Myocardial Infarction (MI)\] within 3 months of surgery and not related to the index cardiac procedure
* Pregnancy
* Participation in another interventional clinical trial within 30 days
* Life expectancy less than 30 days from a non-cardiac cause
* Refusal of blood products precluding PCC administration
NEAR YOU
Study locations worldwide
1 siteCheck the individual site’s status and contact the listed study team for current availability.
1 site shown
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WHAT IS BEING STUDIED
Treatments and study groups
Interventions
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.
Study groups: Clinician-Directed Prothrombin Complex Concentrate (PCC) Dosing, Rotational Thromboelastometry (ROTEM) guided Prothrombin Complex Concentrate (PCC) Dosing
ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH)
ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH), an FDA-cleared point-of-care coagulation monitoring device used to guide PCC dosing decisions.
Study groups: Rotational Thromboelastometry (ROTEM) guided Prothrombin Complex Concentrate (PCC) Dosing
Study groups
Rotational Thromboelastometry (ROTEM) guided Prothrombin Complex Concentrate (PCC) Dosing
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.
Interventions: Drug: Four Factor Prothrombin Complex Concentrate, Device: ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH)
Clinician-Directed Prothrombin Complex Concentrate (PCC) Dosing
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
Interventions: Drug: Four Factor Prothrombin Complex Concentrate
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomized
- Study model
- Parallel
- Masking
- None (open label)
- Enrolment
- 70 participants · Estimated
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 1 Dec 2026 · Estimated
- Primary completion
- Nov 2027 · Estimated
- Study completion
- Nov 2027 · Estimated
- First registered
- 19 Oct 2026 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (1)
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
Secondary outcomes (9)
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
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- University of Miami
- Sponsor type
- Other
- Collaborators
- Not reported
- Organisation study ID
- 20261034
Central study contacts
Study officials
Jake Rachiele, MDPrincipal investigator · University of Miami
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.