Status:

COMPLETED

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

Lead Sponsor:

Centre Hospitalier Universitaire de Saint Etienne

Conditions:

Cardiac Surgery Requiring Extracorporeal Circulation

Eligibility:

All Genders

18+ years

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 t...

Eligibility Criteria

Inclusion

  • Patients benefiting from scheduled or emergency at the Saint-Etienne University Hospital (coronary artery bypass grafting, valve replacements, aortic dissections).

Exclusion

  • 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.

Key Trial Info

Start Date :

November 13 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 12 2021

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT04092868

Start Date

November 13 2019

End Date

March 12 2021

Last Update

March 26 2021

Active Locations (1)

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1

CHU Saint-Etienne

Saint-Etienne, France, 42055