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PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

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ClinicalTrials.gov Identifier: NCT02557672
Recruitment Status : Completed
First Posted : September 23, 2015
Results First Posted : June 7, 2022
Last Update Posted : June 7, 2022
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Gregory A. Nuttall, M.D., Mayo Clinic

Study Description
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Brief Summary:
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?

Condition or disease Intervention/treatment Phase
Bleeding Blood Loss, Surgical Cardiovascular Surgical Procedures Prothrombin Complex Concentrates Fresh Frozen Plasma Drug: Prothrombin complex concentrate (Human) Biological: Fresh frozen plasma (FFP) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 2021
Actual Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Kcentra


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT02557672


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
CSL Behring
Investigators
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Principal Investigator: Gregory Nuttall, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Gregory A. Nuttall, M.D., Mayo Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] November 2, 2020

More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gregory A. Nuttall, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02557672    
Other Study ID Numbers: 14-009579
First Posted: September 23, 2015    Key Record Dates
Results First Posted: June 7, 2022
Last Update Posted: June 7, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
 Thrombin
Hemostatics
Coagulants