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Clinical Trial Summary

Protamine is currently used during cardiac surgery to neutralize unfractionated heparin (UFH) at the end of extra-corporeal circulation (ECC). The optimal dose of protamine is currently unknown, and the administration of protamine is done empirically. Protamine and UFH pharmacokinetics are characterized by a large inter-individual variability. A dose of protamine proportional to the amount of UFH administrated during the surgery may be therefore not adapted to most of the patients and exposed them to a risk of under or over dosage. In this study, research investigators hypothesize that an accurate characterization of the pharmacokinetic/pharmacodynamic (PK/PD) relationship of protamine may help to optimize propose an optimal dosing regimen.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04092868
Study type Observational
Source Centre Hospitalier Universitaire de Saint Etienne
Contact
Status Completed
Phase
Start date November 13, 2019
Completion date March 12, 2021