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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000859-14 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cardiac surgery with extracorporeal circulation | during the operation Intervention Blood sample : - Choay Heparin (pharmacokinetic) concentration: t = 5, 15, 30 minutes after the start of the heparin injection + t = 5, 30, 60 minutes after the start of extracorporeal circulation
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples PK/ PD protamine | Other | PK/ PD protamine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| postoperative blood loss: |
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Inclusion Criteria:
Exclusion Criteria:
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patients with cardiac surgery under CEC
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| Name | Affiliation | Role |
|---|---|---|
| Julien LANOISELÉE, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41638976 | Derived | Lanoiselee J, Gibert A, Gouin-Thibault I, Mansour A, Pontis A, Morizot C, Goset M, Molliex S, Morel J, Noyel P, Azarnoush K, Petrosyan A, Delavenne X, Zufferey PJ, Ollier E. Optimising protamine dosing for heparin reversal after cardiopulmonary bypass: a population pharmacokinetic-pharmacodynamic study. Br J Anaesth. 2026 Mar;136(3):847-855. doi: 10.1016/j.bja.2025.11.057. Epub 2026 Feb 4. |
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quantities of blood loss in pleural and mediastinal drains during the first 24 hours postoperatively. |
| 1 day |
| ratios between the amount of UFH present at the protamine injection and the dose of protamine administered. | 1 day |