Cardiac Surgery Requiring Extracorporeal Circulation Clinical Trial
— PICSOfficial title:
Heparin Antagonization by Protamine in Cardiac Surgery: Pharmacokinetic/Pharmacodynamic Study
| Verified date | March 2021 |
| Source | Centre Hospitalier Universitaire de Saint Etienne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | March 12, 2021 |
| Est. primary completion date | March 12, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Saint-Etienne | Saint-Étienne |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Saint Etienne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PK/PD Protamine | 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. |
1 day | |
| Secondary | PK/PD Protamine | 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 . |
1 day | |
| Secondary | postoperative blood loss: | quantities of blood loss in pleural and mediastinal drains during the first 24 hours postoperatively. | 1 day | |
| Secondary | ratios between the amount of UFH present at the protamine injection and the dose of protamine administered. | 1 day |