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NCT Number: NCT02557672

PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

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?

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Key information

Conditions

Bleeding Blood Loss, Surgical Cardiovascular Surgical Procedures Fresh Frozen Plasma Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Prothrombin Complex Concentrates

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prothrombin complex concentrate (Human)

Drug

PCC (Kcentra)

Other names: Kcentra

Fresh frozen plasma (FFP)

Biological

FFP

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • CSL Behring

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Sep 23, 2015
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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