Heart Disease End StagePhase 3OPSTAHTNCT03341156
Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
A Phase 3 study testing Kcentra and Frozen Plasma Product, Human in people with Heart Disease End Stage and Heart Failure，Congestive, run by University of Maryland, Baltimore at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease End Stage, Heart Failure，Congestive
- What is being tested?
- Kcentra and Frozen Plasma Product, Human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jul 2018to 20 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Be willing and able to provide written informed consent.
- Be at least 18 years of age.
- Patients with or without ventricular assist device (VAD) undergoing heart transplantation
- Patients who have been on warfarin for at least 72 hours before cardiopulmonary bypass procedures for heart transplantation.
- International normalization ration (INR) greater than or equal to 1.5
- Body temperature greater than 35.0 degrees Celsius.
- Blood pH greater than 7.2
- Hemoglobin greater than 7.0 mg/dL.
Who cannot join
- Treatment with clopidogrel, prasugrel, or ticagrelor within 5 days prior to study surgery.
- Known or suspected thrombophilia such as factor V Leiden, hereditary antithrombin III deficiency, heparin-induced thrombocytopenia, disseminated intravascular coagulation.
- Ischemic or thromboembolic events within 6 weeks of study surgery.
- Known allergy/anaphylaxis to prothrombin complex concentrate or albumin.
- Any indication that a potential subject did not comprehend the study restrictions, procedures. or consequences therein an informed consent cannot be convincingly given.
- Patients on respiratory support including extracorporeal membrane oxygenation (ECMO) .
- Life expectancy less than 48 hours.
- Excluded at the discretion of the surgeon based upon surgical safety precautions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland
Baltimore, Maryland, 21201
Upmc Presbyterian Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Optimized Administration of Prothrombin Complex Concentrate (PCC) vs. Standard Transfusion During/After Heart Transplantation - OPSTAHT
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.
Read the detailed description
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.
- Conditions
- Heart Disease End Stage, Heart Failure，Congestive
- Being tested
- Kcentra, Frozen Plasma Product, Human
- Keywords
- Heart transplantation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KcentraDrug
Also called prothrombin complex concentrate
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)
Frozen Plasma Product, HumanDrug
Also called Fresh Frozen Plasma
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.
| Study group | Role | What they receive |
|---|---|---|
| Kcentra (PCC) | Experimental | Half of subjects enrolled will be randomized to the Kcentra (PCC) group. Receives: Drug: Kcentra |
| Frozen Plasma Product, Human | Active comparator | Half of subjects enrolled will be randomized to the standard transfusion group and receive fresh frozen plasma intra-operatively. Receives: Drug: Frozen Plasma Product, Human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Chest Tube Drainage
Primary outcome: Amount of chest tube output in the first 24 hours
Measured: From patient out of room time until 24 hours after
Secondary outcomes (16)
Postoperative INR
INR value
Measured: 30 Minutes post-treatment (after the last dose is completed)
Blood Product Use
Total hemostatic blood product use including plasma, platelets, cryoprecipitate, and recombinant activated factor VII.
Measured: 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
Measured: 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)
Measured: 30 days post-operative or until discharge (whichever comes first)
Mechanical Ventilation
Percentage of patients who needed mechanical ventilation for more than 72 hours
Measured: 30 days post-operative or until discharge (whichever comes first)
Tracheostomy
Percentage of patients who needed a tracheostomy
Measured: 30 days post-operative or until discharge (whichever comes first)
Renal Failure
Percentage of patients who experience renal failure requiring dialysis
Measured: 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.
Measured: 30 days post-operative or until discharge (whichever comes first)
Death
Percentage of patients who died
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days post-operative or until discharge (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start11 Jul 2018
- Primary completion18 Sep 2020
- Study completion20 Feb 2025
Why it stopped: Standard practice change prohibited enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Heart Disease End StageStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor
- Investigators
- Kenichi Tanaka, MD, Principal investigator, University of Maryland, BaltimoreKathirvel Surbramaniam, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341156
- Sponsor's protocol ID
- STUDY19020099
- Acronym
- OPSTAHT
- Status last verified
- May 2025
- First submitted
- 28 Aug 2017
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolliger D, Gorlinger K, Tanaka KA. Pathophysiology and treatment of coagulopathy in massive hemorrhage and hemodilution. Anesthesiology. 2010 Nov;113(5):1205-19. doi: 10.1097/ALN.0b013e3181f22b5a.
PubMed 20881594Mathias T, Puca KE, Downey F, Boyle AJ: Use of Vitamin K and Prothrombin Complex Concentrate as Warfarin Reversal Prior to Heart Transplant. Journal of Heart and Lung Transplantation 2012; 31: S154
Kantorovich A, Fink JM, Militello MA, Wanek MR, Smedira NG, Soltesz EG, Moazami N. Low-dose 3-factor prothrombin complex concentrate for warfarin reversal prior to heart transplant. Ann Pharmacother. 2015 Aug;49(8):876-82. doi: 10.1177/1060028015585344. Epub 2015 May 18.
PubMed 25986007Marshall AL, Levine M, Howell ML, Chang Y, Riklin E, Parry BA, Callahan RT, Okechukwu I, Ayres AM, Nahed BV, Goldstein JN. Dose-associated pulmonary complication rates after fresh frozen plasma administration for warfarin reversal. J Thromb Haemost. 2016 Feb;14(2):324-30. doi: 10.1111/jth.13212. Epub 2016 Feb 2.
PubMed 26644327Demeyere R, Gillardin S, Arnout J, Strengers PF. Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study. Vox Sang. 2010 Oct;99(3):251-60. doi: 10.1111/j.1423-0410.2010.01339.x.
PubMed 20840339Tanaka KA, Mazzeffi MA, Grube M, Ogawa S, Chen EP. Three-factor prothrombin complex concentrate and hemostasis after high-risk cardiovascular surgery. Transfusion. 2013 Apr;53(4):920-1. doi: 10.1111/trf.12110. No abstract available.
PubMed 23565996Song HK, Tibayan FA, Kahl EA, Sera VA, Slater MS, Deloughery TG, Scanlan MM. Safety and efficacy of prothrombin complex concentrates for the treatment of coagulopathy after cardiac surgery. J Thorac Cardiovasc Surg. 2014 Mar;147(3):1036-40. doi: 10.1016/j.jtcvs.2013.11.020. Epub 2013 Dec 22.
PubMed 24365268Rao VK, Lobato RL, Bartlett B, Klanjac M, Mora-Mangano CT, Soran PD, Oakes DA, Hill CC, van der Starre PJ. Factor VIII inhibitor bypass activity and recombinant activated factor VII in cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1221-6. doi: 10.1053/j.jvca.2014.04.015.
PubMed 25281040Balsam LB, Timek TA, Pelletier MP. Factor eight inhibitor bypassing activity (FEIBA) for refractory bleeding in cardiac surgery: review of clinical outcomes. J Card Surg. 2008 Nov-Dec;23(6):614-21. doi: 10.1111/j.1540-8191.2008.00686.x. Epub 2008 Sep 10.
PubMed 18793226Ortmann E, Besser MW, Sharples LD, Gerrard C, Berman M, Jenkins DP, Klein AA. An exploratory cohort study comparing prothrombin complex concentrate and fresh frozen plasma for the treatment of coagulopathy after complex cardiac surgery. Anesth Analg. 2015 Jul;121(1):26-33. doi: 10.1213/ANE.0000000000000689.
PubMed 25822921Goldstein JN, Refaai MA, Milling TJ Jr, Lewis B, Goldberg-Alberts R, Hug BA, Sarode R. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015 May 23;385(9982):2077-87. doi: 10.1016/S0140-6736(14)61685-8. Epub 2015 Feb 27.
PubMed 25728933Tanaka KA, Mazzeffi MA, Strauss ER, Szlam F, Guzzetta NA. Computational simulation and comparison of prothrombin complex concentrate dosing schemes for warfarin reversal in cardiac surgery. J Anesth. 2016 Jun;30(3):369-76. doi: 10.1007/s00540-015-2128-3. Epub 2016 Jan 9.
PubMed 26749482Sarode R, Milling TJ Jr, Refaai MA, Mangione A, Schneider A, Durn BL, Goldstein JN. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013 Sep 10;128(11):1234-43. doi: 10.1161/CIRCULATIONAHA.113.002283. Epub 2013 Aug 9.
PubMed 23935011Subramaniam K. Early graft failure after heart transplantation: prevention and treatment. Int Anesthesiol Clin. 2012 Summer;50(3):202-27. doi: 10.1097/AIA.0b013e3182603ead. No abstract available.
PubMed 22735727Tholpady A, Monson J, Radovancevic R, Klein K, Bracey A. Analysis of prolonged storage on coagulation Factor (F)V, FVII, and FVIII in thawed plasma: is it time to extend the expiration date beyond 5 days? Transfusion. 2013 Mar;53(3):645-50. doi: 10.1111/j.1537-2995.2012.03786.x. Epub 2012 Jul 15.
PubMed 22803679
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Administration of Prothrombin Complex Concentrate (PCC) vs. Standard Transfusion During/After Heart Transplantation - OPSTAHT
- ClinicalTrials.gov ID
- NCT03341156
- Acronym / sponsor ID
- OPSTAHT / STUDY19020099
- Conditions
- Heart Disease End Stage, Heart Failure，Congestive
- Keywords
- Heart transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Standard practice change prohibited enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 14 Nov 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kcentra (PCC) | Experimental | Drug: KcentraHalf of subjects enrolled will be randomized to the Kcentra (PCC) group. |
| Frozen Plasma Product, Human | Active comparator | Drug: Frozen Plasma Product, HumanHalf of subjects enrolled will be randomized to the standard transfusion group and receive fresh frozen plasma intra-operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be willing and able to provide written informed consent.
- Be at least 18 years of age.
- Patients with or without ventricular assist device (VAD) undergoing heart transplantation
- Patients who have been on warfarin for at least 72 hours before cardiopulmonary bypass procedures for heart transplantation.
- International normalization ration (INR) greater than or equal to 1.5
Key exclusion criteria (8 listed)
- Treatment with clopidogrel, prasugrel, or ticagrelor within 5 days prior to study surgery.
- Known or suspected thrombophilia such as factor V Leiden, hereditary antithrombin III deficiency, heparin-induced thrombocytopenia, disseminated intravascular coagulation.
- Ischemic or thromboembolic events within 6 weeks of study surgery.
- Known allergy/anaphylaxis to prothrombin complex concentrate or albumin.
- Any indication that a potential subject did not comprehend the study restrictions, procedures. or consequences therein an informed consent cannot be convincingly given.
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 |
|---|---|---|
| KcentraAlso: prothrombin complex concentrateKcentra 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) | Drug | Kcentra (PCC) |
| Frozen Plasma Product, HumanAlso: Fresh Frozen PlasmaIf 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. | Drug | Frozen Plasma Product, Human |
Primary outcome
Amount of Chest Tube Drainage
Time frame: From patient out of room time until 24 hours after
Primary outcome: Amount of chest tube output in the first 24 hours
16 secondary outcomes
Postoperative INR
Time frame: 30 Minutes post-treatment (after the last dose is completed)
Blood Product Use
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
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
Time frame: 30 days post-operative or until discharge (whichever comes first)
Mechanical Ventilation
Time frame: 30 days post-operative or until discharge (whichever comes first)
Tracheostomy
Time frame: 30 days post-operative or until discharge (whichever comes first)
Renal Failure
Time frame: 30 days post-operative or until discharge (whichever comes first)
Sepsis
Time frame: 30 days post-operative or until discharge (whichever comes first)
Death
Time frame: 30 days post-operative or until discharge (whichever comes first)
Stroke or postoperative neurological dysfunction
Time frame: 30 days post-operative or until discharge (whichever comes first)
Gastrointestinal complication requiring bowel resection
Time frame: 30 days post-operative or until discharge (whichever comes first)
Peripheral vascular complication
Time frame: 30 days post-operative or until discharge (whichever comes first)
Deep Vein Thrombosis and Pulmonary Thromboembolism
Time frame: 30 days post-operative or until discharge (whichever comes first)
Plasma Coagulation Factor levels
Time frame: At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment
Thrombin Generation Assay
Time frame: At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment
Surgical Re-exploration
Time frame: 30 days post-operative or until discharge (whichever comes first)
Results and safety
The study was stopped early (reason given: Standard practice change prohibited enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 20881594Bolliger D, Gorlinger K, Tanaka KA. Pathophysiology and treatment of coagulopathy in massive hemorrhage and hemodilution. Anesthesiology. 2010 Nov;113(5):1205-19. doi: 10.1097/ALN.0b013e3181f22b5a.
- BackgroundMathias T, Puca KE, Downey F, Boyle AJ: Use of Vitamin K and Prothrombin Complex Concentrate as Warfarin Reversal Prior to Heart Transplant. Journal of Heart and Lung Transplantation 2012; 31: S154
- Background: PubMed 25986007Kantorovich A, Fink JM, Militello MA, Wanek MR, Smedira NG, Soltesz EG, Moazami N. Low-dose 3-factor prothrombin complex concentrate for warfarin reversal prior to heart transplant. Ann Pharmacother. 2015 Aug;49(8):876-82. doi: 10.1177/1060028015585344. Epub 2015 May 18.
- Background: PubMed 26644327Marshall AL, Levine M, Howell ML, Chang Y, Riklin E, Parry BA, Callahan RT, Okechukwu I, Ayres AM, Nahed BV, Goldstein JN. Dose-associated pulmonary complication rates after fresh frozen plasma administration for warfarin reversal. J Thromb Haemost. 2016 Feb;14(2):324-30. doi: 10.1111/jth.13212. Epub 2016 Feb 2.
- Background: PubMed 20840339Demeyere R, Gillardin S, Arnout J, Strengers PF. Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study. Vox Sang. 2010 Oct;99(3):251-60. doi: 10.1111/j.1423-0410.2010.01339.x.
- Background: PubMed 23565996Tanaka KA, Mazzeffi MA, Grube M, Ogawa S, Chen EP. Three-factor prothrombin complex concentrate and hemostasis after high-risk cardiovascular surgery. Transfusion. 2013 Apr;53(4):920-1. doi: 10.1111/trf.12110. No abstract available.
- Background: PubMed 24365268Song HK, Tibayan FA, Kahl EA, Sera VA, Slater MS, Deloughery TG, Scanlan MM. Safety and efficacy of prothrombin complex concentrates for the treatment of coagulopathy after cardiac surgery. J Thorac Cardiovasc Surg. 2014 Mar;147(3):1036-40. doi: 10.1016/j.jtcvs.2013.11.020. Epub 2013 Dec 22.
- Background: PubMed 25281040Rao VK, Lobato RL, Bartlett B, Klanjac M, Mora-Mangano CT, Soran PD, Oakes DA, Hill CC, van der Starre PJ. Factor VIII inhibitor bypass activity and recombinant activated factor VII in cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1221-6. doi: 10.1053/j.jvca.2014.04.015.
- Background: PubMed 18793226Balsam LB, Timek TA, Pelletier MP. Factor eight inhibitor bypassing activity (FEIBA) for refractory bleeding in cardiac surgery: review of clinical outcomes. J Card Surg. 2008 Nov-Dec;23(6):614-21. doi: 10.1111/j.1540-8191.2008.00686.x. Epub 2008 Sep 10.
- Background: PubMed 25822921Ortmann E, Besser MW, Sharples LD, Gerrard C, Berman M, Jenkins DP, Klein AA. An exploratory cohort study comparing prothrombin complex concentrate and fresh frozen plasma for the treatment of coagulopathy after complex cardiac surgery. Anesth Analg. 2015 Jul;121(1):26-33. doi: 10.1213/ANE.0000000000000689.
- Background: PubMed 25728933Goldstein JN, Refaai MA, Milling TJ Jr, Lewis B, Goldberg-Alberts R, Hug BA, Sarode R. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015 May 23;385(9982):2077-87. doi: 10.1016/S0140-6736(14)61685-8. Epub 2015 Feb 27.
- Background: PubMed 26749482Tanaka KA, Mazzeffi MA, Strauss ER, Szlam F, Guzzetta NA. Computational simulation and comparison of prothrombin complex concentrate dosing schemes for warfarin reversal in cardiac surgery. J Anesth. 2016 Jun;30(3):369-76. doi: 10.1007/s00540-015-2128-3. Epub 2016 Jan 9.
- 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. This study is not recruiting at the moment.
Kenichi Tanaka, MD principal investigator
University of Maryland, Baltimore
Kathirvel Surbramaniam, MD principal investigator
University of Pittsburgh Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kcentra and Frozen Plasma Product, Human in people with Heart Disease End Stage and Heart Failure，Congestive, run by University of Maryland, Baltimore at 3 sites 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Standard practice change prohibited enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Chest Tube Drainage (time frame: From patient out of room time until 24 hours after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341156, which also lists 17 linked publications.
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 23 May 2025.