Clinical trial

Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery

Name
LowProt
Description
Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.
Trial arms
Trial start
2024-03-15
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Not yet recruiting
Treatment
Low dose protamine
Administration of 70% of the normal dose of protamine
Arms:
Low dose of Protamine, Normal dose of protamine
Size
50
Primary endpoint
Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.
24 hours
Eligibility criteria
Inclusion Criteria: * Mini-sternotomy aortic valve replacement surgery * Major patients Exclusion Criteria: * Hypersensitivity to protamine * Coagulation Abnormalities * Heparin allergy * Pregnant women * Jehovah's Witnesses
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-02-12

1 organization

1 product

2 indications

Product
Protamine
Indication
Protamine Dose