Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 73 of 199 for:    Protamine

Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation (OPSTAHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03341156
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
University of Maryland, College Park
CSL Behring
Information provided by (Responsible Party):
Kathirvel Subramaniam, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Disease End Stage Heart Failure,Congestive Drug: Kcentra Drug: Frozen Plasma Product, Human Phase 3

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, during surgery and at 24 hours after surgery.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimized Administration of Prothrombin Complex Concentrate (PCC) vs. Standard Transfusion During/After Heart Transplantation - OPSTAHT
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021


Arm Intervention/treatment
Experimental: Kcentra (PCC)
Half of subjects enrolled will be randomized to the Kcentra (PCC) group.
Drug: Kcentra
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)
Other Name: prothrombin complex concentrate

Active Comparator: Frozen Plasma Product, Human
Half of subjects enrolled will be randomized to the standard transfusion group and receive fresh frozen plasma intra-operatively.
Drug: Frozen Plasma Product, Human
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.
Other Name: Fresh Frozen Plasma




Primary Outcome Measures :
  1. Percentage of patients who received RBC Transfusion [ Time Frame: From infusion until 24 hours post-heart transplant ]
    Co-Primary outcome: The percentage of patients who received more than 4 units of RBC transfusion in the first 24 hours postoperatively.

  2. Amount of Chest Tube Drainage [ Time Frame: From infusion until 24 hours post-heart transplant ]
    Co-Primary outcome: The percentage of patients who had more than 1000 mL of chest tube drainage in the first 24 hours postoperatively.


Secondary Outcome Measures :
  1. Postoperative INR [ Time Frame: 30 Minutes post-infusion ]
    Percentage of patients with INR less than or equal to 1.5.

  2. Blood Product Use [ Time Frame: Collected every 24 hours after surgery up to 30 days ]
    24- hour total hemostatic blood product use including plasma, platelets, cryoprecipitate, and recombinant activated factor VII.

  3. Surgical Re-exploration [ Time Frame: 24 Hours post-hear transplant ]
    Percentage of patients who needed surgical re-exploration

  4. Need for circulatory support [ Time Frame: 30 days post-heart transplant ]
    Percentage of patients who needed circulatory support (ECMO or VAD)

  5. Mechanical Ventilation [ Time Frame: 30 days post-heart transplant ]
    Percentage of patients who needed mechanical ventilation for more than 72 hours

  6. Tracheostomy [ Time Frame: 30 Days post-heart transplant ]
    Percentage of patients who needed a tracheostomy

  7. Renal Failure [ Time Frame: 30 Days post-heart transplant ]
    Percentage of patients who experience renal failure requiring dialysis

  8. Sepsis [ Time Frame: 30 Days post-heart transplant ]
    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.

  9. Death [ Time Frame: 30 Days post heart transplant ]
    Percentage of patients who died

  10. Stroke or postoperative neurological dysfunction [ Time Frame: 30 Days post heart transplant ]
    Percentage of patients who experienced a stroke or postoperative neurological dysfunction (seizures, delirium, unconsciousness, encephalopathy)

  11. Gastrointestinal complication requiring bowel resection [ Time Frame: 30 days post heart transplant ]
    Percentage of patients who experienced gastrointestinal complications requiring bowel resection

  12. Peripheral vascular complication [ Time Frame: 30 Days post heart transplant ]
    Percentage of patients who experience peripheral vascular complications requiring surgery (thrombectomy, bypass, and amputations)

  13. Deep Vein Thrombosis and Pulmonary Thromboembolism [ Time Frame: 30 Days post heart transplant ]
    Percentage of patients who develop a deep vein thrombosis and/ or pulmonary thromboembolism

  14. Plasma Coagulation Factor levels [ Time Frame: From baseline until 24 hours post-heart transplant ]
    Plasma coagulator factor levels will be analyzed via blood laboratory tests

  15. Thrombin Generation Assay [ Time Frame: From baseline until 24 hours post-heart transplant ]
    Thrombin Generation assay will be analyzed via blood laboratory tests


Other Outcome Measures:
  1. Direct Cost Benefit [ Time Frame: From infusion until 30 days post heart transplant ]
    Acquisition costs for test agents and blood bank related charges (thawing, etc.)

  2. Total surgical time [ Time Frame: Intaoperatively from anesthesia start until anesthesia stop ]
    Total time of surgical duration will be measured in the corresponding time frame

  3. Time to hospital discharge [ Time Frame: from infusion until discharge from the hospital or until 30 days post heart transplant ]
    Time until discharge from the hospital post study intervention will be measured

  4. Time to Intensive Care Unit (ICU) discharge [ Time Frame: From infusion until discharge from the ICU or until 30 days post heart transplant ]
    Time until discharge from the ICU post study intervention will be measured

  5. Indirect Cost Benefits [ Time Frame: From infusion until 30 days post heart transplant ]
    Extra costs related to study drug (PCC and plasma) related complications (volume overload, thrombotic complications)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341156


Contacts
Layout table for location contacts
Contact: Amy Monroe 412-623-6382 Monroeal@upmc.edu
Contact: Caroline E. Kostishack 412-623-1586 caroline.kostishack@chp.edu

Locations
Layout table for location information
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kenichi Tanaka, M.D.    410-328-9813      
Contact: LaToya Stubbs       lstubbs@som.umaryland.edu   
United States, Pennsylvania
Upmc Presbyterian Montefiore Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: KATHIRVEL SUBRAMANIAM, MD    412-647-5635    subramaniamk@upmc.edu   
Contact: AMY MONROE, MPH    4126096161    monroeal@upmc.edu   
UPMC Presbyterian Shadyside Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kathirvel Subramaniam, M.D.    412-647-5635    subramaniamk@upmc.edu   
Contact: Amy Monroe    4126236382    Monroeal@upmc.edu   
Sponsors and Collaborators
Kathirvel Subramaniam
University of Maryland, College Park
CSL Behring
Investigators
Layout table for investigator information
Principal Investigator: Kenichi Tanaka, MD University of Maryland, College Park
Principal Investigator: Kathirvel Surbramaniam, MD University of Pittsburgh Medical Center

Publications:
Mathias 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
CSLBehring: Prescribing informaiton for Kcentra (Prothrombin complex concentrate, human). Kankakee, IL, CSL Behring 2014, pp September 15. Subramaniam K. Early graft failure after heart transplantation: prevention and treatment. Int Anesthesiol Clin. 2012 Summer;50(3):202-27.

Layout table for additonal information
Responsible Party: Kathirvel Subramaniam, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03341156     History of Changes
Other Study ID Numbers: PRO17080509
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kathirvel Subramaniam, University of Pittsburgh:
Heart transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Thrombin
Hemostatics
Coagulants