Heparin Antagonization by Protamine in Cardiac Surgery: Pharmacokinetic/Pharmacodynamic Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-13

Study Completion Date

2021-03-12

Brief Summary

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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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Detailed Description

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Conditions

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Cardiac Surgery Requiring Extracorporeal Circulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

* protamine dosage: t = 2, 5, 8, 10 and 15 min after protamine injection
* anti-X activity t = 0 before administration and at time 2, 5, 8, 10 and 15 min then at time 1, 3, 5, 6 and 7 hours after protamine injection
* thrombin generation test (TGT) activity (thrombinography) : t = 2, 5, 8, 10 and 15 min after protamine injection

Blood samples PK/ PD protamine

Intervention Type OTHER

PK/ PD protamine

Interventions

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Blood samples PK/ PD protamine

PK/ PD protamine

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No