PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

May 16, 2022 updated by: Gregory A. Nuttall, M.D., Mayo Clinic

Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for Post-cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center.

This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

Genders Eligible for Study

All

Description

Inclusion Criteria

All subjects accepted for this study must:

  • Be 18 years of age
  • Be undergoing elective cardiac surgical procedure utilizing cardiopulmonary bypass
  • Have evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team in addition to a PT >16.6 sec or INR >1.6 sec.

Exclusion Criteria

Subjects who have one or more of the following will be excluded from the study:

  • Are unable to grant informed consent or comply with study procedure
  • History of hypercoagulable condition (e.g. Factor V Leiden, AT-3 deficiency, Prothrombin gene mutation, Anti-phospholipid antibody syndrome, etc) or previous unprovoked thromboembolic complications
  • Coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at the time of cardiovascular surgery
  • Thromboembolic event within past 3 months
  • Received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within the past 5 days
  • Patients taking chronic warfarin therapy who have not discontinued treatment and demonstrated an INR <1.3 prior to surgery
  • Fibrinogen level <150 mg/dL on initial post cardiopulmonary bypass labs
  • Antithrombin 3 level < 80% control (preoperative)
  • Are undergoing emergency open heart-surgery
  • Cardiopulmonary bypass time is expected to be < 30 minutes
  • Age < 18 years of age
  • Are pregnant

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
Active Comparator: Fresh frozen plasma
After cardiopulmonary bypass, patients will receive protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, will be collected via preexisting arterial access. If ACT >10% baseline additional protamine will be given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field will occur 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec will receive fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Biological: Fresh frozen plasma (FFP)
FFP
Experimental: Prothrombin complex concentrate
After cardiopulmonary bypass, patients will receive protamine at dose 0.01 mg/unit of heparin given with target ACT within 10% of baseline value. After protamine administration the ACT, CBC, PT/ INR, APTT, and fibrinogen, will be collected via preexisting arterial access. If ACT >10% baseline additional protamine will be given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field will occur 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT >16.6 sec/ INR >1.6 sec will receive Prothrombin complex concentrate (Human) 15 units/kg.
Drug: Prothrombin complex concentrate (Human)
PCC (Kcentra)
Other Names:
  • Kcentra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest Tube Output
Time Frame: 24 hours
The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL.
24 hours
Red Blood Cell (RBC) Blood Product Transfusion
Time Frame: 24 hours
The number of subject's who received 0,1,2,3 or more units of RBC's transfused from completion of study drug administration though midnight of the next day.
24 hours
Platelets Blood Product Transfusion
Time Frame: 24 hours
The number of subject's who received 0,1,2,3 or more units of Platelets transfused from completion of study drug administration though midnight of the next day.
24 hours
Cryoprecipitate (Cryo) Blood Product Transfusion
Time Frame: 24 hours
The number of subject's who received 0,1,2,3 or more units of Cryo's transfused from completion of study drug administration though midnight of the next day.
24 hours
Fresh Frozen Plasma (FFP) Blood Product Transfusion
Time Frame: 24 hours
The number of subject's who received 0,1,2,3 or more units of FFP's transfused from completion of study drug administration though midnight of the next day.
24 hours

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

CSL Behring

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

Helpful Links

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)

August 1, 2016

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-009579

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

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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