NCT03335995 (SPICE) is a clinical trial in Acute Stroke Patients Requiring Invasive Mechanical Ventilation, sponsored by Institut National de la Santé Et de la Recherche Médicale, France.

Who is sponsoring NCT03335995?

NCT03335995 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France.

What condition does NCT03335995 study?

NCT03335995 studies Acute Stroke Patients Requiring Invasive Mechanical Ventilation.

Is NCT03335995 still recruiting?

NCT03335995 is currently completed. Last updated 3 October 2025.

Last reviewed 2025-10-03 · How we verify

NCT03335995: SPICE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Stroke Prognosis in Intensive CarE

Completed Last updated 3 October 2025

What this trial tests

trial in Acute Stroke Patients Requiring Invasive Mechanical Ventilation in 364 participants. Completed in 18 November 2020.

Timeline

18 October 2017

Primary endpoint
18 November 2019

18 November 2020

Quick facts

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Status	Completed
Study type	OBSERVATIONAL
Enrollment	364
Start date	18 October 2017
Primary completion	18 November 2019
Estimated completion	18 November 2020
Sites	1 location across France

Conditions studied

Acute Stroke Patients Requiring Invasive Mechanical Ventilation — all drugs for Acute Stroke Patients Requiring Invasive Mechanical Ventilation →

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France — full company profile →

Who can join

Adults 18 to 85, any sex, with Acute Stroke Patients Requiring Invasive Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

One-Year Outcomes in Patients With Acute Stroke Requiring Mechanical Ventilation.
Sonneville R, Mazighi M, Collet M, Gayat E, et al · · 2023 · cited 12× · PMID 37497675 · DOI 10.1161/strokeaha.123.042910
Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study.
Sonneville R, Mazighi M, Bresson D, Crassard I, et al · · 2020 · cited 8× · PMID 32026446 · DOI 10.1007/s12028-019-00907-0
Development and validation of a nomogram for predicting 28-day mortality in patients with ischemic stroke.
Fang L, Zhou M, Mao F, Diao M, et al · · 2024 · cited 5× · PMID 38656987 · DOI 10.1371/journal.pone.0302227
Prognostic value of early EEG abnormalities in severe stroke patients requiring mechanical ventilation: a pre-planned analysis of the SPICE prospective multicenter study.
Benghanem S, Kubis N, Gayat E, Loiodice A, et al · · 2024 · cited 3× · PMID 38783313 · DOI 10.1186/s13054-024-04957-5
ESICM LIVES 2022: part 2.
· 2022 · cited 3× · PMID 36258052 · DOI 10.1186/s40635-022-00469-0
Proceedings of Reanimation 2023, the French Intensive Care Society International Congress.
· 2023 · cited 2× · PMID 37311846 · DOI 10.1186/s13613-023-01131-y
Association between invasive intracranial pressure monitoring and 1-year functional outcome in ICU patients with severe stroke: a pre-planned ancillary study of the SPICE prospective cohort (SPICE-ICP).
Rolland D, Sonneville R, Mazighi M, Pari MH, et al · · 2026 · PMID 41881341 · DOI 10.1016/j.accpm.2026.101838

Verify or expand the search:

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

Trials by the same sponsor.

NCT07311213 — GENES AND AUTISM - IPSC · NA · not yet recruiting
NCT07063719 — Identification of Cellular Biomarkers of Rare Eye Diseases in Adults · NA · not yet recruiting
NCT06906042 — Multimodal Cardiovascular and Hepatic Population Imaging · recruiting
NCT06951035 — Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic Stroke · NA · not yet recruiting
NCT06660108 — MOLECULAR BASIS OF LANGUAGE DEVELOPMENT AND ASSOCIATED DISORDERS · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03335995 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut National de la Santé Et de la Recherche Médicale, France
Last refreshed: 3 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03335995.

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