Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass (Heparin Dosing)
Primary Purpose
Postoperative Hemorrhage
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Heparin
HH or high heparin
heparin concentration HC
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Hemorrhage focused on measuring heparin management
Eligibility Criteria
Inclusion Criteria:
- Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.
Exclusion Criteria:
- Age less than 18 or greater than 90 years; emergency surgery
- Circulatory arrest
- Combined non-cardiac procedures such as carotid endarterectomy
- Congenital heart repair
- Off-CPB coronary artery bypass grafting (CABG)
- Clotting disorder
- Fibrinolytic agents (e.g. streptokinase), severe hepatic disease
- Aprotinin use
- Cooling < 28 degrees C during CPB
- Dialysis dependent renal failure; and
- Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
control standard dose heparin dose
high dose heparin dose
hepcon guided therapy
Outcomes
Primary Outcome Measures
measure blood loss
Secondary Outcome Measures
transfusion requirements
Full Information
NCT ID
NCT00587444
First Posted
December 21, 2007
Last Updated
October 14, 2009
Sponsor
Mayo Clinic
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00587444
Brief Title
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Acronym
Heparin Dosing
Official Title
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study has been completed and is in the data analysis and manuscript writing phase of the project.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage
Keywords
heparin management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
control standard dose heparin dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
high dose heparin dose
Arm Title
3
Arm Type
Active Comparator
Arm Description
hepcon guided therapy
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
300u/kg of heparin for CPB ACT performed. If ACT is < 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is>480 seconds
Intervention Type
Drug
Intervention Name(s)
HH or high heparin
Intervention Description
initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB
Intervention Type
Drug
Intervention Name(s)
heparin concentration HC
Intervention Description
will have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB.
All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10%
Primary Outcome Measure Information:
Title
measure blood loss
Time Frame
within 48 hours
Secondary Outcome Measure Information:
Title
transfusion requirements
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.
Exclusion Criteria:
Age less than 18 or greater than 90 years; emergency surgery
Circulatory arrest
Combined non-cardiac procedures such as carotid endarterectomy
Congenital heart repair
Off-CPB coronary artery bypass grafting (CABG)
Clotting disorder
Fibrinolytic agents (e.g. streptokinase), severe hepatic disease
Aprotinin use
Cooling < 28 degrees C during CPB
Dialysis dependent renal failure; and
Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Oliver, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
12. IPD Sharing Statement
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Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
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