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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
  Purpose
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
Acute Stroke Patients Requiring Invasive Mechanical Ventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stroke Prognosis in Intensive CarE - The SPICE Registry

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 300
Actual Study Start Date: October 18, 2017
Estimated Study Completion Date: April 18, 2019
Estimated Primary Completion Date: June 18, 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03335995


Contacts
Contact: Mikael MAZIGHI 01 48 03 63 33 mmazighi@for.paris,
Contact: Romain SONNEVILLE 01 48 25 61 39 romain.sonneville@aphp.fr

Locations
France
Bichat Hospital Recruiting
Paris, France, 75018
Contact: Romain SONNEVILLE    0140256139    romain.sonneville@aphp.fr   
Contact: Rusheenthira THAVASEELAN    0140257223    rusheenthira.thavaseelan-ext@aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Jean-François TIMSIT U 1137
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03335995     History of Changes
Other Study ID Numbers: C17-16
First Submitted: October 19, 2017
First Posted: November 8, 2017
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
prognosis
stroke

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