Stroke Prognosis in Intensive CarE (SPICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03335995
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : November 9, 2017
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
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).

Condition or disease
Acute Stroke Patients Requiring Invasive Mechanical Ventilation

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stroke Prognosis in Intensive CarE - The SPICE Registry
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : June 18, 2018
Estimated Study Completion Date : April 18, 2019

Primary Outcome Measures :
  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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The subjects included in this study are major patients, victims of an AVC, having been admitted in ICU and having required an invasive artificial ventilation in the aigüe phase of their AVC ( 7 days).

The future of these patients can be marked by a prolonged invasive ventilation of several weeks in several months or by a death in ICU or in another department of the hospital of short stay, or afterward, in their place of residence or in the various existing structures of average and long stay.

The future can also be a strong support. The patients needing no more invasive ventilation, are transferred by the ICU towards another department of care then, in the best case, return at home. The routes of care of these patients are varied according to their needs.


Inclusion Criteria:

  • Age>18 years
  • Victim of an AVC, whatever is the type(chap): ischaemia, brain haemorrhage, sub-arachnoid bleeding. The diagnosis of this AVC is radiological, the date of the diagnosis is defined by the date of the initial brain imaging (TDM or MRI).
  • Hospitalized in ICU in 7 days before or after the diagnosis of AVC.
  • Requiring an invasive mechanical ventilation of more than 24 hours during the stay in ICU.

Exclusion Criteria:

  • Source of traumatic AVC
  • Refusal of the patient, or his reliable person, to participate in the study.
  • Patient undergoing the safeguard of justice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03335995

Contact: Mikael MAZIGHI 01 48 03 63 33,
Contact: Romain SONNEVILLE 01 48 25 61 39

Bichat Hospital Recruiting
Paris, France, 75018
Contact: Romain SONNEVILLE    0140256139   
Contact: Rusheenthira THAVASEELAN    0140257223   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Study Director: Jean-François TIMSIT U 1137

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France Identifier: NCT03335995     History of Changes
Other Study ID Numbers: C17-16
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
mechanical invasive ventilation
course of the care

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases