Use and safety of aprotinin in routine clinical practice: A European postauthorisation safety study conducted in patients undergoing cardiac surgery.

ABSTRACT:

Background

Aprotinin has been used to reduce blood loss and blood product transfusions in patients at high risk of major blood loss during cardiac surgery. Approval by the European Medicines Agency (EMA) for its current indication is limited to patients at high risk of major blood loss undergoing isolated coronary artery bypass graft surgery (iCABG).

Objective

To report current real-world data on the use and certain endpoints related to the safety of aprotinin in adult patients.

Design

The Nordic aprotinin patient registry (NAPaR) received data from 83 European centres in a noninterventional, postauthorisation safety study (PASS) performed at the request of the EMA.

Setting

Cardiac surgical centres committed to enrolling patients in the NAPaR.

Patients

P

SUBMITTER: De Hert S 

PROVIDER: S-EPMC9451913 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature