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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • measure blood loss [ Time Frame: within 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • transfusion requirements [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 270
Study Start Date: June 2001
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%


  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. William Oliver, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587444     History of Changes
Other Study ID Numbers: 330-01, 3300100, CR4023159908
Study First Received: December 21, 2007
Last Updated: October 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
heparin management

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014