Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass.

• Status: Completed
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Protamine is routinely used as a heparin reversal agent in cardiac surgery. However, its use may be associated with adverse events, while protamine excess may have additional anti-coagulant affect. Although guidelines advise towards a diminished reversal ratio, clinical practice remain heterogenic. The purpose of this study is to compare two different reversal ratios (0.6:1 και 0.8:1) of total heparin regarding the Activated Clotting Time (ACT), viscoelastic assays (Clot-Pro) and clinical hemorrhage.

A baseline ACT value and Clot Pro tests will be obtained prior to the operation start. After the initial reversal, ACT, Clot Pro tests will be conducted again. Coagulation factors are administrated according to Clot Pro results, and in case of ongoing clinical hemorrhage and any indication of heparin excess in the measured values, another 25mg of protamine is administrated, while tests are repeated.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ioannina
• Treatments: Protamines

Criteria

Inclusion Criteria:

• Age > 18 years

• Agreement to participate

• Scheduled for elective cardiac surgery on cardiopulmonary by-pass (CPB)

Exclusion Criteria:

• Age <18 years.

• No consent

• Known allergy to heparin or protamine

• History of Heparin Induced Thrombocytopenia (HIT)

• Off pump surgery