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Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass (Heparin Dosing)

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ClinicalTrials.gov Identifier: NCT00587444
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : October 15, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Postoperative Hemorrhage Drug: Heparin Drug: HH or high heparin Drug: heparin concentration HC Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Study Start Date : June 2001
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
1
control standard dose heparin dose
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
Active Comparator: 2
high dose heparin dose
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
Active Comparator: 3
hepcon guided therapy
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%



Outcome Measures

Primary Outcome Measures :
  1. measure blood loss [ Time Frame: within 48 hours ]

Secondary Outcome Measures :
  1. transfusion requirements [ Time Frame: 48 hours ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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): NCT00587444


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
Principal Investigator: William Oliver, MD Mayo Clinic
More Information

Responsible Party: Dr. William Oliver, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587444     History of Changes
Other Study ID Numbers: 330-01
3300100
CR4023159908
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Mayo Clinic:
heparin management

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action