Cardiac Surgery Requiring Extracorporeal Circulation
Conditions
Brief 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.
Interventions
OTHERBlood samples PK/ PD protamine
PK/ PD protamine
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients benefiting from scheduled or emergency at the Saint-Etienne University Hospital (coronary artery bypass grafting, valve replacements, aortic dissections).
Exclusion criteria
* Patients with a contraindication to UFH * Patients with a contraindication to protamine * Patients requiring early resurgery. * Patients receiving an injection of antithrombin III. * Pregnant women. * Patient for whom aprotinin use is planned during surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK/PD Protamine | 1 day | Pharmacokinetics (PK) : plasma concentration of protamine measured by liquid chromatography coupled with mass spectrometry. Pharmacodynamics (PD) :The effect of protamine corresponds to the kinetics of the disappearance of UFH in the blood. To do this, the investigators measure its concentration using an anti-Xa activity measurement technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK/PD Protamine | 1 day | PK: evolution of protamine concentrations over time (plasma concentration of protamine measured by liquid chromatography coupled with mass spectrometry). PD: ts neutralizing effect evaluated by thrombinography . |
| postoperative blood loss: | 1 day | quantities of blood loss in pleural and mediastinal drains during the first 24 hours postoperatively. |
| ratios between the amount of UFH present at the protamine injection and the dose of protamine administered. | 1 day | — |
Countries
France
Outcome results
None listed