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Stroke Prognosis in Intensive CarE (SPICE)

This study is currently recruiting participants.
Verified November 2017 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT03335995
First Posted: November 8, 2017
Last Update Posted: November 9, 2017
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.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
October 19, 2017
November 8, 2017
November 9, 2017
October 18, 2017
June 18, 2018   (Final data collection date for primary outcome measure)
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).
Functional outcome [ Time Frame: One year ]
Score on the modified Rankin scale
Complete list of historical versions of study NCT03335995 on ClinicalTrials.gov Archive Site
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Stroke Prognosis in Intensive CarE
Stroke Prognosis in Intensive CarE - The SPICE Registry
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Acute Stroke Patients Requiring Invasive Mechanical Ventilation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 18, 2019
June 18, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact: Mikael MAZIGHI 01 48 03 63 33 mmazighi@for.paris,
Contact: Romain SONNEVILLE 01 48 25 61 39 romain.sonneville@aphp.fr
France
 
 
NCT03335995
C17-16
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Study Director: Jean-François TIMSIT U 1137
Institut National de la Santé Et de la Recherche Médicale, France
November 2017