Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Postoperative Hemorrhage

Treatments: Drug: heparin concentration HC; Drug: Heparin; Drug: HH or high heparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00587444

330-01

3300100

CR4023159908

Details and patient eligibility

About

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

Enrollment: 270 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 3 patient groups

1

Other group

Description:

control standard dose heparin dose

Treatment:

Drug: Heparin

2

Active Comparator group

Description:

high dose heparin dose

Treatment:

Drug: HH or high heparin

3

Active Comparator group

Description:

hepcon guided therapy

Treatment:

Drug: heparin concentration HC