Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass - Full Text View

Sponsors and Collaborators:	Mayo Clinic Medtronic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587444

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 III

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

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:	September 2003
Estimated Primary Completion Date:	January 2009 (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
2: Active Comparator 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
3: Active Comparator 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

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:	Mayo Clinic ( Dr. William Oliver )
Study ID Numbers:	330-01, 3300100, CR4023159908
Study First Received:	December 21, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00587444 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

heparin management

Study placed in the following topic categories:

Thrombin
Anticoagulants
Postoperative Hemorrhage
Benzocaine
Fibrinolytic Agents
Cardiovascular Agents
Hemorrhage

Calcium heparin
Calcium, Dietary
Fibrin Modulating Agents
Postoperative Complications
Protamines
Heparin

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Postoperative Hemorrhage
Fibrinolytic Agents
Cardiovascular Agents
Hemorrhage

Pharmacologic Actions
Calcium heparin
Fibrin Modulating Agents
Pathologic Processes
Postoperative Complications
Therapeutic Uses
Heparin

ClinicalTrials.gov processed this record on May 07, 2009