Stroke Prognosis in Intensive CarE

NCT ID: NCT03335995

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-18

Study Completion Date

2020-11-18

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Stroke Patients Requiring Invasive Mechanical Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-François TIMSIT

Role: STUDY_DIRECTOR

U 1137

Locations

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Bichat Hospital

Paris, , France

Site Status

Countries

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France

References

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Sonneville R, Mazighi M, Collet M, Gayat E, Degos V, Duranteau J, Gregoire C, Sharshar T, Naim G, Cortier D, Jost PH, Foucrier A, Bagate F, de Montmollin E, Papin G, Magalhaes E, Guidet B, Ben Hadj Salem O, Benghanem S, le Guennec L, Delpierre E, Legriel S, Megarbane B, Toumert K, Tran M, Geri G, Monchi M, Bodiguel E, Mariotte E, Demoule A, Zarka J, Diehl JL, Roux D, Barre E, Tanaka S, Osman D, Pasquier P, Lamara F, Crassard I, Boursin P, Ruckly S, Staiquly Q, Timsit JF, Woimant F; SPICE Investigators. One-Year Outcomes in Patients With Acute Stroke Requiring Mechanical Ventilation. Stroke. 2023 Sep;54(9):2328-2337. doi: 10.1161/STROKEAHA.123.042910. Epub 2023 Jul 27.

Reference Type BACKGROUND
PMID: 37497675 (View on PubMed)

Sonneville R, Mazighi M, Bresson D, Crassard I, Crozier S, de Montmollin E, Degos V, Faugeras F, Gayat E, Josse L, Lamy C, Magalhaes E, Maldjian A, Ruckly S, Servan J, Vassel P, Vigue B, Timsit JF, Woimant F; SPICE investigators. Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study. Neurocrit Care. 2020 Apr;32(2):624-629. doi: 10.1007/s12028-019-00907-0.

Reference Type BACKGROUND
PMID: 32026446 (View on PubMed)

Other Identifiers

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C17-16

Identifier Type: -

Identifier Source: org_study_id

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