Cardiac Surgery Clinical Trial
Official title:
Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass.
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | April 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Ioannina | Ioannina | Epirus |
Lead Sponsor | Collaborator |
---|---|
University of Ioannina |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Activated Clotting Time (in seconds) | ACT values after heparin reversal | Intraoperatively | |
Primary | Viscoelastic testing | CT-HI/CT-IN TEST values ratio after heparin reversal | Intraoperatively | |
Secondary | Transfusion | Number of blood products (RBC, FFP, PLT) administered to the patients | Intraoperatively and up to 24 hours postoperatively | |
Secondary | Clotting factors | Number of Clotting factors (PCCs, fibrinogen etc) administered to the patient | Intraoperatively and up to 24 hours postoperatively | |
Secondary | Postoperative hemorrhage | Total volume of blood drains and need for re-operation due to postoperative hemorrhage | 24 hours postoperatively | |
Secondary | ICU LOS | Total ICU Length of Stay | Up to 30 days |
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