Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587444
First received: December 21, 2007
Last updated: October 14, 2009
Last verified: October 2009

December 21, 2007
October 14, 2009
June 2001
October 2007   (final data collection date for primary outcome measure)
measure blood loss [ Time Frame: within 48 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00587444 on ClinicalTrials.gov Archive Site
transfusion requirements [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Study has been completed and is in the data analysis and manuscript writing phase of the project.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Hemorrhage
  • Drug: Heparin
    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
  • Drug: HH or high heparin
    initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB
  • Drug: heparin concentration HC

    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%

  • 1
    control standard dose heparin dose
    Intervention: Drug: Heparin
  • Active Comparator: 2
    high dose heparin dose
    Intervention: Drug: HH or high heparin
  • Active Comparator: 3
    hepcon guided therapy
    Intervention: Drug: heparin concentration HC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587444
330-01, 3300100, CR4023159908
Yes
Dr. William Oliver, Mayo Clinic
Mayo Clinic
Medtronic
Principal Investigator: William Oliver, MD Mayo Clinic
Mayo Clinic
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP