A REtrospective Study to discOver the economic impLications of Vasospasm and delayed cErebral ischaemia (RESOLVE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50205
• EU PAS number:
  EUPAS50204
• Study ID:
  50205
• Official title and acronym:
  A REtrospective Study to discOver the economic impLications of Vasospasm and delayed cErebral ischaemia (RESOLVE)
• 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 retrospective, nationwide, multi-centre observational cohort study which aims to assess the healthcare resource utilization (HCRU) and clinical outcomes associated with the development of delayed cerebral ischaemia (DCI) following aneurysmal subarachnoid haemorrhage (aSAH). The study will use existing patient data held in medical charts and the Système National des Données de Santé (SNDS), the French national healthcare database. A total of 300 patients with aSAH will be recruited by eleven centres across France via consecutive stratified recruitment to obtain an approximately equal number of DCI and non-DCI patients. Physicians will be asked to extract relevant retrospective data from medical charts of patients admitted to their centre between 1st January 2017 and 31st December 2018. Patient chart data will be linked with data from the SNDS to obtain more comprehensive HCRU data and longer-term data on patient outcomes including mortality.
• Study status:
  Finalised

Research institutions and networks

Institutions

Evidence and Access/Analytica Laser, Certara

France

United Kingdom (Northern Ireland)

Multiple centres: 11 centres are involved in the study

Networks

BELIEVE Scientific Committee

Study timelines

Date when funding contract was signed

Planned: 23/11/2021

Actual: 23/11/2021

Study start date

Planned: 15/01/2023

Actual: 06/02/2023

Data analysis start date

Planned: 01/06/2023

Date of final study report

Planned: 31/12/2024

Actual: 06/02/2023

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