Back to resultsPCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
Primary Purpose
Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prothrombin complex concentrate (Human)
Fresh frozen plasma (FFP)
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fresh frozen plasma
Prothrombin complex concentrate
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Chest Tube Output
The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL.
Red Blood Cell (RBC) Blood Product Transfusion
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.
Platelets Blood Product Transfusion
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.
Cryoprecipitate (Cryo) Blood Product Transfusion
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.
Fresh Frozen Plasma (FFP) Blood Product Transfusion
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02557672
First Posted
September 21, 2015
Last Updated
May 16, 2022
Sponsor
Mayo Clinic
Collaborators
CSL Behring
1. Study Identification
Unique Protocol Identification Number
NCT02557672
Brief Title
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
January 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
CSL Behring
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates, Fresh Frozen Plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fresh frozen plasma
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prothrombin complex concentrate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prothrombin complex concentrate (Human)
Other Intervention Name(s)
Kcentra
Intervention Description
PCC (Kcentra)
Intervention Type
Biological
Intervention Name(s)
Fresh frozen plasma (FFP)
Intervention Description
FFP
Primary Outcome Measure Information:
Title
Chest Tube Output
Description
The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL.
Time Frame
24 hours
Title
Red Blood Cell (RBC) Blood Product Transfusion
Description
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.
Time Frame
24 hours
Title
Platelets Blood Product Transfusion
Description
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.
Time Frame
24 hours
Title
Cryoprecipitate (Cryo) Blood Product Transfusion
Description
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.
Time Frame
24 hours
Title
Fresh Frozen Plasma (FFP) Blood Product Transfusion
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Nuttall, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
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