Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

NCT00587444 | Completed Phase 3 DMC

• 3 other identifiers: 330-013300100CR4023159908
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Hemorrhage

Keywords

heparin management

Outcome Measures

Primary Outcomes (1)

• measure blood loss

  within 48 hours

Secondary Outcomes (1)

• transfusion requirements

  48 hours

Study Arms (3)

1

OTHER

control standard dose heparin dose

Drug: Heparin

2

ACTIVE COMPARATOR

high dose heparin dose

Drug: HH or high heparin

3

ACTIVE COMPARATOR

hepcon guided therapy

Drug: heparin concentration HC

Interventions

Heparin DRUG

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

1

HH or high heparin DRUG

initial dose of 450u/kg for CPB ACT performed additional bolus given if result is \<600 seconds anytime during CPB

2

heparin concentration HC DRUG

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%

3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Medtronic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Heparin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• William Oliver, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: June 1, 2001
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 15, 2009

Record last verified: 2009-10

Locations

US (1)