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

May 19, 2025 updated by: University of Maryland, Baltimore

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Upmc Presbyterian Montefiore Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Shadyside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • Excluded at the discretion of the surgeon based upon surgical safety precautions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Fresh Frozen Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From patient out of room time until 24 hours after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative INR
Time Frame: 30 Minutes post-treatment (after the last dose is completed)
INR value
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)
Total hemostatic blood product use including plasma, platelets, cryoprecipitate, and recombinant activated factor VII.
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)
Red Blood Cell Use Intraoperatively and Postoperatively
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)
Percentage of patients who needed circulatory support (ECMO or VAD)
30 days post-operative or until discharge (whichever comes first)
Mechanical Ventilation
Time Frame: 30 days post-operative or until discharge (whichever comes first)
Percentage of patients who needed mechanical ventilation for more than 72 hours
30 days post-operative or until discharge (whichever comes first)
Tracheostomy
Time Frame: 30 days post-operative or until discharge (whichever comes first)
Percentage of patients who needed a tracheostomy
30 days post-operative or until discharge (whichever comes first)
Renal Failure
Time Frame: 30 days post-operative or until discharge (whichever comes first)
Percentage of patients who experience renal failure requiring dialysis
30 days post-operative or until discharge (whichever comes first)
Sepsis
Time Frame: 30 days post-operative or until discharge (whichever comes first)
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.
30 days post-operative or until discharge (whichever comes first)
Death
Time Frame: 30 days post-operative or until discharge (whichever comes first)
Percentage of patients who died
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)
Percentage of patients who experienced a stroke or postoperative neurological dysfunction (seizures, delirium, unconsciousness, encephalopathy)
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)
Percentage of patients who experienced gastrointestinal complications requiring bowel resection
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)
Percentage of patients who experience peripheral vascular complications requiring surgery (thrombectomy, bypass, and amputations)
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)
Percentage of patients who develop a deep vein thrombosis and/ or pulmonary thromboembolism
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
Plasma coagulator factor levels will be analyzed via blood laboratory tests
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
Thrombin Generation assay will be analyzed via blood laboratory tests
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)
Surgical Re-Exploration that is related to heart transplant surgery
30 days post-operative or until discharge (whichever comes first)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
From infusion until 30 days post heart transplant
Total surgical time
Time Frame: From anesthesia start time until anesthesia stop time
Total time of surgical duration will be measured in the corresponding time frame
From anesthesia start time until anesthesia stop time
Time to hospital discharge
Time Frame: From patient out of room time to hospital discharge (or 30 days post heart transplant, whichever comes first)
Time until discharge from the hospital post study intervention will be measured
From patient out of room time to hospital discharge (or 30 days post heart transplant, whichever comes first)
Time to Intensive Care Unit (ICU) discharge
Time Frame: From patient out of room time to ICU discharge (or 30 days post heart transplant, whichever comes first)
Time until discharge from the ICU post study intervention will be measured
From patient out of room time to ICU discharge (or 30 days post heart transplant, whichever comes first)
Indirect Cost Benefits
Time Frame: From last intervention/infusion until 30 days post heart transplant or until discharge
Extra costs related to study drug (PCC and plasma) related complications (volume overload, thrombotic complications)
From last intervention/infusion until 30 days post heart transplant or until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

CSL Behring

Investigators

  • Principal Investigator: Kathirvel Surbramaniam, MD, University of Pittsburgh Medical Center
  • Principal Investigator: Kenichi Tanaka, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Actual)

September 18, 2020

Study Completion (Actual)

February 20, 2025

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19020099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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