Cardiopulmonary BypassPhase 4NCT07881393
Prothrombin Complex Concentrate (PCC)
A Phase 4 study testing Four Factor Prothrombin Complex Concentrate and ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH) in people with Cardiopulmonary Bypass, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Four Factor Prothrombin Complex Concentrate and ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami Hospital
Miami, Florida, 33136
Chandrama Shrestha, 305-585-7677, cxs1555@med.miami.edu
About this study
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
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.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Four Factor Prothrombin Complex Concentrate, ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four Factor Prothrombin Complex ConcentrateDrug
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)Device
ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH), an FDA-cleared point-of-care coagulation monitoring device used to guide PCC dosing decisions.
| Study group | Role | What they receive |
|---|---|---|
| Rotational Thromboelastometry (ROTEM) guided Prothrombin Complex Concentrate (PCC) Dosing | Experimental | 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. Receives: Drug: Four Factor Prothrombin Complex Concentrate; Device: ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH) |
| Clinician-Directed Prothrombin Complex Concentrate (PCC) Dosing | Active comparator | 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 Receives: Drug: Four Factor Prothrombin Complex Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days following the index surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jake Rachiele, University of Miami
- Investigators
- Jake Rachiele, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881393
- Sponsor's protocol ID
- 20261034
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07881393
- Acronym / sponsor ID
- 20261034
- Conditions
- Cardiopulmonary Bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational Thromboelastometry (ROTEM) guided Prothrombin Complex Concentrate (PCC) Dosing | Experimental | 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. 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. |
| Clinician-Directed Prothrombin Complex Concentrate (PCC) Dosing | Active comparator | Drug: Four Factor Prothrombin Complex ConcentrateParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four Factor Prothrombin Complex Concentrate4-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. | Drug | 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. | Device | Rotational Thromboelastometry (ROTEM) guided Prothrombin Complex Concentrate (PCC) Dosing |
Primary outcome
Total 24-Hour Chest Tube Drainage Volume (mL)
Time frame: 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.
9 secondary outcomes
Participants With Unplanned Return to the Operating Room Within 24 Hours
Time frame: Within 24 hours after completion of the index surgical procedure
Total 4F-PCC Dose Administered (IU)
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Units of packed red blood cells (pRBC) transfused
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Units of Fresh Frozen Plasma Transfused
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Platelet Units Transfused
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Number of Cryoprecipitate Units Transfused
Time frame: From the start of the index surgical procedure through 24 hours postoperatively
Duration of mechanical ventilation (hours)
Time frame: From endotracheal intubation until successful extubation, up to 30 days postoperatively
Intensive Care Unit Length of Stay length of stay (Days)
Time frame: From ICU admission through ICU discharge, up to 30 days postoperatively
30-day all-cause mortality
Time frame: 30 days following the index surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jake Rachiele, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Four Factor Prothrombin Complex Concentrate and ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH) in people with Cardiopulmonary Bypass, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chandrama Shrestha (305-585-7677, cxs1555@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 24-Hour Chest Tube Drainage Volume (mL) (time frame: From surgical closure through 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.