Clinical trial

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

Name
179/23-2-2023
Description
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.
Trial arms
Trial start
2023-03-18
Estimated PCD
2024-04-30
Trial end
2024-04-30
Status
Completed
Treatment
Protamin
ACT and Clot- Pro test will be ran after initial and possible next protamine administrations
Arms:
0.6:1, 0.8:1
Other names:
viscoelastic testing (Clot-Pro), ACT
Size
98
Primary endpoint
Activated Clotting Time (in seconds)
Intraoperatively
Viscoelastic testing
Intraoperatively
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 98, 'type': 'ACTUAL'}}
Updated at
2024-05-31

1 organization

1 product

4 indications

Product
Protamin
Indication
Cardiac surgery