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

October 19, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
INR Value Less Than 1.5
Time Frame: 30min Post-Protamine

30 min after the administration of study drug (Kcentra or FFP)
30min Post-Protamine
Hemostatic Blood Products
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, and cryoprecipitate.
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)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CSL Behring

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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