Study identification

EU PAS number

EUPAS48706

Study ID

49584

Official title and acronym

PRospective obsErvational Study to quantify thE buRden of illness of Vasospasm and delayed cErebral ischaemia (PRESERVE)

DARWIN EU® study

No

Study countries

France

Study description

**This study was terminated prematurely for reasons unrelated to any safety or patient-related concerns, as no data was collected no report will be produced ** This is a prospective, nationwide, multi-centre observational cohort study which aims to assess the humanistic burden of illness associated with the development of delayed cerebral ischaemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH). The study will utilise survey methods to administer validated and bespoke questionnaires to patients with aSAH and their principal caregiver. A total of 400 participants with aSAH will be recruited by eleven centres across France. Participating hospitals will provide details regarding the aSAH event and clinically relevant details by completing an electronic case report form at patient hospital discharge. After discharge, patient and caregiver questionnaires will be administered at 3-, 6- and 12-months following date of patient aneurysmal securing procedure. The participants functional status, activities of daily living, employment and productivity, as well as quality of life will be assessed. In addition, the participant’s caregiver burden and work and productivity will be assessed.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 11 centres are involved in the study

Networks

BELIEVE Scientific Committee

Contact details

Louis Puybasset

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Idorsia Pharmaceuticals Ltd
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable