Clinical Trial Comparing Heparin and Protamine Fixed and Titrated Doses in Cardiac Surgery With Cardiopulmonary Bypass

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

There are currently several schemes described for anticoagulation with heparin and its reversal with protamine during cardiac surgery with CPB. The oldest, and most used in our routine environment, is the scheme of fixed doses, in which a bolus dose of heparin at the start of CPB is established in IU/kg of body weight and the dose of protamine at the end of CPB is calculated based on the initial dose of heparin administered.

These schemes do not take into account the variability inter-patients and can result in overdose or sub-doses of one or both drugs.

The titration schedule of doses of heparin and protamine through the principle of dose-response curve of Bull promotes individualization of dosage according to the response of each patient. This scheme has been associated with an effective reversal of the effect of heparin after CPB and with reduction of post-operatory bleeding and transfusion.

The restoration of a state of anticoagulation by heparin after its reversal by protamine is called "rebound effect". It is a phenomenon explained by the recirculation of heparin stored in the reticulum-endothelial system and connective tissue, or by free residual concentration of heparin after clearance of protamine. This effect may be present for more than 6 hours of post-operatory and may contribute to increase post-operatory bleeding.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SANE-Society of Anesthesiology
• Collaborators: Fundação Universitária de Cardiologia (University Foundation of Cardiology); Instituto de Cardiologia do Rio Grande do Sul
• Treatments: Calcium heparin; Heparin; Protamines

Criteria

Inclusion Criteria:

• Patients submitted to an Elective Cardiac Surgery with Cardiopulmonary Bypass

• Age 18 to 75 years-old

Exclusion Criteria:

• Hematocrit < 30

• INR > 1,3

• Platelets < 100,000

• Altered KTTP

• Receiving Non-fractioned Heparin or Low-Molecular Weight Heparin

• Renal Insufficiency or Creatinine > 2,0

• Liver Failure or altered ALT/AST

• Von Willebrands'disease, Haemophilia, sepsis

• Use in the past 7 days of antiplatelet-therapy(Ticlopidine or Clopidogrel)