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Completed

NCT Number: NCT03335995

Stroke Prognosis in Intensive CarE

The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following ICU admission. This project is funded by the French Agence Régionale de Santé (ARS).

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Key information

Conditions

Acute Stroke Patients Requiring Invasive Mechanical Ventilation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bichat Hospital

Paris, 75018, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18 years
  • Acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). The stroke diagnosis date is defined by the date of the initial brain imaging (TDM or MRI).
  • Admitted to ICU within 7 days before or after the diagnosis of stroke.
  • Requiring invasive mechanical ventilation in ICU for more than 24 hours.

Exclusion criteria

  • Traumatic causes of stroke
  • Refusal of the patient, or his reliable person, to participate in the study.
  • Privation of liberty by administrative or judicial decision

Treatment and study plan

Primary outcomes

  1. Functional outcome

    Time frame: One year

    Score on the modified Rankin scale (a disability score that ranges from 0 [no symptoms] to 6 [death]). Patients will be classified as "good outcome" (score of 0-3) or poor outcome (score of 4-6, indicating severe disability or death).

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Stroke Prognosis in Intensive CarE - The SPICE Registry

Acronym: SPICE

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 8, 2017
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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