Non-interventional post-authorisation safety study of pattern of use of Nordic Aprotinin (Nordic Aprotinin Patient Registry)

Study identification

• EU PAS number:
  EUPAS11384
• Study ID:
  40238
• Official title and acronym:
  Non-interventional post-authorisation safety study of pattern of use of Nordic Aprotinin (Nordic Aprotinin Patient Registry)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  Finland

  France

  Germany

  Ireland

  Netherlands

  Sweden

  United Kingdom
• Study description:
  The Nordic Aprotinin Patient Registry is a multicentre, non-interventional Post Authorisation Safety Study with active surveillance via patient exposure registry. Nordic will supply Nordic Aprotinin only to centres that perform cardiac surgery on cardio-pulmonary bypass and which commit to enrol in the Nordic Aprotinin Patient Registry (participating centres). The Nordic Aprotinin Patient Registry is designed to be easy-to-use and to fit with standard clinical practice. The Registry is intended to record utilisation information on virtually all patients at cardiac surgery centres exposed to the product beginning from the day that Nordic Aprotinin becomes available to the market, and continuing for at least three years thereafter. Nordic will provide appropriate training and support to facilitate implementation of the Registry at all participating centres. Nordic will encourage all participating centres to treat only patients conforming to the authorised indications for Nordic Aprotinin. According to the national legislation of the countries involved, Nordic will carefully monitor the number of cases in which Nordic Aprotinin is given to patients having surgery outside the authorised use and will collect data on these patients via the Registry (use outside cardiac surgery is expected to be negligible due to the limitation of supply to cardiothoracic centres) however if there is any such use, it will be monitored carefully and discussed in the PSUR. The proposed Registry will provide information on the number of patients who receive Nordic Aprotinin by centre, indication (cardiac surgical procedure, indication features) for which Nordic Aprotinin was administered, and the conditions of use, including dose and adherence to instructions for administration in the approved SmPC. Interim and progress reports will be provided to the PRAC (and the National Competent Authorities if required) and will include summary tables of analyses of patterns of use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:07/12/2015

Actual:07/12/2015

Study start date

Planned:30/06/2015

Actual:26/02/2016

Data analysis start date

Planned:07/01/2020

Actual:07/01/2020

Date of interim report, if expected

Actual:04/05/2018

Date of final study report

Planned:31/12/2020

Actual:19/01/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nordic Group B.V.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)