A Phase 3 interventional study of Kcentra and Frozen Plasma Product, Human in Heart Disease End Stage and Heart Failure，Congestive, sponsored by University of Maryland, Baltimore. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Maryland, Baltimore · Phase 3, Interventional, and Treatment
This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.
This study will be a randomized (1:1; PCC vs. plasma), open-label trial of hemostatic therapies during heart transplantation. The goal is to enroll 60 patients. Informed consent will be obtained from patients meeting the inclusion and exclusion criteria before the initiation of any study specific procedures. Eligible patients will be randomized to receive either PCC or plasma transfusion. The efficacy of interventions will be evaluated after 30 minutes of protamine administration. After the heart transplantation, thrombocytopenia and/or hypofibrinogenemia may worsen bleeding associated with vitamin K dependent factor deficiencies. Transfusion of platelets and/or cryoprecipitate is permitted if abnormal laboratory values are observed during the rewarming phase of CPB; platelet count \<100 x 103/µl, and fibrinogen \<200 mg/dl, respectively. Laboratory tests (hematocrit, platelet count, PT, PTT, POC-PT, coagulation factor and inhibitor levels (e.g., factor II, antithrombin), thromboelastometry or thromboelastography, endogenous thrombin generation) will also be obtained at baseline, twice during surgery and at 12-24 hours after surgery.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 14 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half of subjects enrolled will be randomized to the Kcentra (PCC) group.
Drug: Kcentra
Half of subjects enrolled will be randomized to the standard transfusion group and receive fresh frozen plasma intra-operatively.
Drug: Frozen Plasma Product, Human
Kcentra will be administered in 2 divided doses; Pre-bypass (5-10 units/kg based on body weight and preoperative INR and post-protamine based of the pre-bypass dose and the preoperative INR; daily maximum dose not to exceed 5000 IU (50 IU/kg)
Also known as: prothrombin complex concentrate
If the patient is randomized to receive standard transfusion they will receive 2 U of fresh frozen plasma intravenously before cardiopulmonary bypass and then up to 4-8 U of plasma added to the cardiopulmonary bypass reservoir during rewarming.
Also known as: Fresh Frozen Plasma
Amount of Chest Tube Drainage
Primary outcome: Amount of chest tube output in the first 24 hours
Time frame: From patient out of room time until 24 hours after
Postoperative INR
INR value
Time frame: 30 Minutes post-treatment (after the last dose is completed)
INR Value Less Than 1.5
30 min after the administration of study drug (Kcentra or FFP)
Time frame: 30min Post-Protamine
Hemostatic Blood Products
Total hemostatic blood product use, including plasma, platelets, and cryoprecipitate.
Time frame: In OR (from OR entry to OR out of room time); postoperatively (patient out of room time) to 24 hours after; from 24 hours after until 30 days post surgery or until discharge (whichever comes first)
Red Blood Cell Use
Red Blood Cell Use Intraoperatively and Postoperatively
Time frame: Intraoperatively(from start of first intervention until start of second intervention;after 2nd intervention(post-bypass)until patient out of room time) & Postoperatively(from patient out of room time until 24 hours after;24 hours after until 30 days)
Need for Circulatory Support
Percentage of patients who needed circulatory support (ECMO or VAD)
Time frame: 30 days post-operative or until discharge (whichever comes first)
Mechanical Ventilation
Percentage of patients who needed mechanical ventilation for more than 72 hours
Time frame: 30 days post-operative or until discharge (whichever comes first)
Tracheostomy
Percentage of patients who needed a tracheostomy
Time frame: 30 days post-operative or until discharge (whichever comes first)
Renal Failure
Percentage of patients who experience renal failure requiring dialysis
Time frame: 30 days post-operative or until discharge (whichever comes first)
Sepsis
Percentage of patients who experienced sepsis infection morbidity consisted of sepsis syndrome, septic shock, or mediastinitis. In addition, the diagnosis of sepsis included organisms isolated from the cultures along with elevated temperature and white blood cell counts.
Time frame: 30 days post-operative or until discharge (whichever comes first)
Death
Percentage of patients who died
Time frame: 30 days post-operative or until discharge (whichever comes first)
Stroke or Postoperative Neurological Dysfunction
Percentage of patients who experienced a stroke or postoperative neurological dysfunction (seizures, delirium, unconsciousness, encephalopathy)
Time frame: 30 days post-operative or until discharge (whichever comes first)
Gastrointestinal Complication Requiring Bowel Resection
Percentage of patients who experienced gastrointestinal complications requiring bowel resection
Time frame: 30 days post-operative or until discharge (whichever comes first)
Peripheral Vascular Complication
Percentage of patients who experience peripheral vascular complications requiring surgery (thrombectomy, bypass, and amputations)
Time frame: 30 days post-operative or until discharge (whichever comes first)
Deep Vein Thrombosis and Pulmonary Thromboembolism
Percentage of patients who develop a deep vein thrombosis and/ or pulmonary thromboembolism
Time frame: 30 days post-operative or until discharge (whichever comes first)
Plasma Coagulation Factor Levels
Plasma coagulator factor levels will be analyzed via blood laboratory tests
Time frame: At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment
Thrombin Generation Assay
Thrombin Generation assay will be analyzed via blood laboratory tests
Time frame: At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment
Surgical Re-exploration
Surgical Re-Exploration that is related to heart transplant surgery
Time frame: 30 days post-operative or until discharge (whichever comes first)
Patients were enrolled between July 2018 and January 2020. Enrollment paused during COVID-19. After COVID-19 and changes heart transplant surgery practices the study was ended. Patients were enrolled in the preoperative area or intensive care unit on the day of surgery or the day prior. Patients were screened weekly and with updated heart transplantation notification from the surgical service. Patient were then approached if they met all inclusion criteria without any exclusion criteria.
| Milestone | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Started | 8 | 6 |
| Completed | 7 | 5 |
| Not completed | 1 | 1 |
| Withdrew: Case cancellation | 1 | 1 |
Primary outcome: Amount of chest tube output in the first 24 hours
| Milliliters | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Amount of Chest Tube Drainage | 1582.9 (673.1 to 2492.6) | 1108.5 (850 to 1367) |
INR value
| INR | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Postoperative INR | 1.4 ± 2.3 | 1.7 ± 4.3 |
30 min after the administration of study drug (Kcentra or FFP)
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| INR Value Less Than 1.5 | 4 | 0 |
Total hemostatic blood product use, including plasma, platelets, and cryoprecipitate.
| Units | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Intraoperative FFP | 0.7 (-0.4 to 1.8) | 10.3 (2.6 to 17.7) |
| 24hr FFP | 1.8 (0.2 to 3.5) | 2.7 (-2.5 to 7.8) |
| 24hr to 30 day FFP | 0 (0 to 0) | 0 (0 to 0) |
| Intraoperative Platelet | 1.9 (0.9 to 2.8) | 3.2 (1.2 to 5.2) |
| 24hr Platelet | 1 (-0.1 to 2.1) | 0.3 (-1.1 to 1.8) |
| 24hr to 30 day Platelet | 2 (-0.8 to 4.8) | 0.5 (-1.1 to 2.1) |
| Intraoperative Cryoprecipitate | 2.6 (1.7 to 3.5) | 3.8 (1.3 to 6.3) |
| 24hr Cryoprecipitate | 0.7 (-0.4 to 1.9) | 0 (0 to 0) |
| 24hr to 30 day Cryoprecipitate | 0.6 (-0.3 to 1.5) | 0 (0 to 0) |
Red Blood Cell Use Intraoperatively and Postoperatively
| Units | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| 1st Intervention | 3.1 (1.3 to 5) | 2.0 (-0.6 to 4.6) |
| 2nd Intervention | 0.1 (-0.2 to 0.5) | 3.2 (-5 to 11.4) |
| 24-hour Postoperative RBC | 3.3 (-0.2 to 6.8) | 3 (-0.4 to 6.4) |
| 24hr to 30 day Postoperative RBC | 3.6 (0.1 to 7.0) | 3.3 (-8.9 to 15.6) |
Percentage of patients who needed circulatory support (ECMO or VAD)
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Need for Circulatory Support | 2 | 1 |
Percentage of patients who needed mechanical ventilation for more than 72 hours
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Mechanical Ventilation | 5 | 2 |
Percentage of patients who needed a tracheostomy
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Tracheostomy | 1 | 0 |
Percentage of patients who experience renal failure requiring dialysis
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Renal Failure | 1 | 0 |
Percentage of patients who experienced sepsis infection morbidity consisted of sepsis syndrome, septic shock, or mediastinitis. In addition, the diagnosis of sepsis included organisms isolated from the cultures along with elevated temperature and white blood cell counts.
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Sepsis | 0 | 0 |
Percentage of patients who died
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Death | 1 | 0 |
Percentage of patients who experienced a stroke or postoperative neurological dysfunction (seizures, delirium, unconsciousness, encephalopathy)
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Stroke or Postoperative Neurological Dysfunction | 2 | 0 |
Percentage of patients who experienced gastrointestinal complications requiring bowel resection
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Gastrointestinal Complication Requiring Bowel Resection | 0 | 0 |
Percentage of patients who experience peripheral vascular complications requiring surgery (thrombectomy, bypass, and amputations)
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Peripheral Vascular Complication | 0 | 0 |
Percentage of patients who develop a deep vein thrombosis and/ or pulmonary thromboembolism
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Deep Vein Thrombosis and Pulmonary Thromboembolism | 1 | 0 |
Plasma coagulator factor levels will be analyzed via blood laboratory tests
| IU/mL | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Factor II baseline | 0.35 (0.23 to 0.47) | 0.29 (0.15 to 0.43) |
| Factor II Pre-protamine | 0.25 (0.13 to 0.37) | 0.37 (0.23 to 0.52) |
| Factor II 30min Post-protamine | 0.53 (0.41 to 0.65) | 0.37 (0.24 to 0.53) |
| Factor II 12-24hr Post-Intervention | 0.61 (0.49 to 0.73) | 0.60 (0.45 to 0.76) |
| Factor IX Baseline | 0.42 (0.28 to 0.57) | 0.37 (0.19 to 0.54) |
| Factor IX Pre-protamine | 0.28 (0.13 to 0.42) | 0.37 (0.19 to 0.54) |
| Factor IX 30min Post-protamine | 0.49 (0.34 to 0.64) | 0.37 (0.19 to 0.54) |
| Factor IX 12-24hr Post-intervention | 0.56 (0.41 to 0.70) | 0.53 (0.34 to 0.72) |
| Factor VII Baseline | 0.26 (0.16 to 0.36) | 0.22 (0.11 to 0.34) |
| Factor VII Pre-Protamine | 0.14 (0.04 to 0.23) | 0.23 (0.12 to 0.35) |
| Factor VII 30min Post-Protamine | 0.42 (0.32 to 0.52) | 0.31 (0.19 to 0.43) |
| Factor VII 12-24hr Post-Intervention | 0.57 (0.47 to 0.67) | 0.48 (0.36 to 0.61) |
| Factor X Baseline | 0.22 (0.11 to 0.34) | 0.18 (0.04 to 0.31) |
| Factor X Pre-Protamine | 0.19 (0.08 to 0.31) | 0.30 (0.16 to 0.43) |
| Factor X 30min Post-Protamine | 0.54 (0.42 to 0.65) | 0.33 (0.19 to 0.46) |
| Factor X 12-24hr Post-Intervention | 0.60 (0.49 to 0.72) | 0.62 (0.47 to 0.78) |
Thrombin Generation assay will be analyzed via blood laboratory tests
| Nanomolar | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Basline | 182.7 ± 105.4 | 187.7 ± 150.9 |
| Post-Cardiopulmonary Bypass/Pre-Protamine | 115.0 ± 48.8 | 176.3 ± 88.6 |
| 30 minutes Post-Protamine | 385.0 ± 253.0 | 293.9 ± 159.4 |
| 12-24 hr Post-Intervention | 390.2 ± 89.0 | 363.3 ± 66.2 |
Surgical Re-Exploration that is related to heart transplant surgery
| Participants | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Surgical Re-exploration | 4 | 3 |
Collected over Adverse events at discharge or 30 days, which every comes first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kcentra (PCC) | 1/7 (14.3%) | 2/7 (28.6%) | 0/7 (0%) |
| Frozen Plasma Product, Human | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Event | Kcentra (PCC) | Frozen Plasma Product, Human |
|---|---|---|
| Thrombotic EventsBlood and lymphatic system disorders | 2/7 | 0/5 |
| Stroke/Neurological DysfunctionNervous system disorders | 2/7 | 0/5 |
| Renal FailureRenal and urinary disorders | 1/7 | 0/5 |
| Pulmonary EmbolismsBlood and lymphatic system disorders | 0/7 | 0/5 |
| Age, Continuous(years) | Kcentra (PCC) | Frozen Plasma Product, Human | Total |
|---|---|---|---|
| Mean | 56.4 ± 15 | 58.4 ± 9.3 | 58.1 ± 11.5 |
| Sex: Female, Male(Participants) | Kcentra (PCC) | Frozen Plasma Product, Human | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 5 | 5 | 10 |
| Race (NIH/OMB)(Participants) | Kcentra (PCC) | Frozen Plasma Product, Human | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 3 | 3 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BMI(kg/m^2) | Kcentra (PCC) | Frozen Plasma Product, Human | Total |
|---|---|---|---|
| Mean | 25.5 ± 5.3 | 30.9 ± 4.1 | 27.8 ± 5.4 |
| CKD(Participants) | Kcentra (PCC) | Frozen Plasma Product, Human | Total |
|---|---|---|---|
| Count of participants | 4 | 2 | 6 |
| Ventricular Assits Devices(Participants) | Kcentra (PCC) | Frozen Plasma Product, Human | Total |
|---|---|---|---|
| Count of participants | 6 | 5 | 11 |
| COPD(Participants) | Kcentra (PCC) | Frozen Plasma Product, Human | Total |
|---|---|---|---|
| Count of participants | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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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Studies of the drug tested here: Four-factor Prothrombin Complex Concentrate
University of Maryland, Baltimore →