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OpenTrials
Completed

NCT Number: NCT00587444

Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

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

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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%

Primary outcomes

  1. measure blood loss

    Time frame: within 48 hours

Secondary outcomes

  1. transfusion requirements

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Medtronic

Registry information

Acronym: Heparin Dosing

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Jan 7, 2008
Registry last updated
Oct 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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