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Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage (EVAPROPEC)

This study is currently recruiting participants.
Verified March 2016 by Centre Hospitalier Universitaire de Besancon
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773200
First Posted: January 23, 2013
Last Update Posted: March 31, 2016
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):
Centre Hospitalier Universitaire de Besancon
  Purpose

Aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate of mortality and morbidity. Severe definitive neurological impairment can concern up to 30% of patients in relation with elevated intracranial pressure, hemorrhage recurrence and symptomatic cerebral arterial vasospasm. This latter complication is defined as a reversible reduction of cerebral artery's diameter occurring between the 4th and the 14th day after bleeding. Physiopathology is not well understood, but could involve endothelium, trough endothelial progenitor cells (EPC). Circulating EPC are bone marrow-derived cells with capacity of vasculogenesis and angiogenesis. EPC have been recognized playing a beneficial role in cardiovascular disease and ischemic stroke. EPC have never been studied in aneurysmal subarachnoid hemorrhage.

The primary objective of this study is to compare the number of circulating endothelial progenitor cells between patients with a good neurological outcome (defined as a glasgow outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale = 3, 4 or 5).

Briefly, the number of circulating EPC will be measured at admission, and at day 3, 6, 10, 14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and hospitalized in Teaching Hospital of Besançon (France). The neurological outcome will be measured one year after subarachnoid hemorrhage.


Condition
Aneurysmal Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage (Evaluation de l'intérêt Pronostic Des progéniteurs endothéliaux Circulants Dans l'hémorragie Sous-arachnoïdienne Par Rupture d'anévrysme cérébral)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • endothelial progenitor cells count [ Time Frame: day 3 after bleeding ]

Secondary Outcome Measures:
  • Endothelial progenitor cells count [ Time Frame: day 0, 6, 10, 14, 21 after bleeding ]
  • Maximal amplitude of variation of EPC count [ Time Frame: 3 weeks after bleeding ]
  • Plasmatic brain natriuretic peptide [ Time Frame: day 0, 3, 6, 10, 14, 21 after bleeding ]

Other Outcome Measures:
  • Glasgow Outcome Scale [ Time Frame: One year after bleeding ]
  • Vasospasm occurence [ Time Frame: during the 3 weeks after bleeding ]

    Vasospasm will be defined as at less one segmental narrowing of a cerebral artery diagnosed on cerebral angiography (angio scanner, angio-MRI or 4 axes cerebral arteriography). Cerebral angiography will be done as necessary according to the occurence of the following situations

    • a clinical neurological deterioration unexplained by another cause
    • a mean arterial blood flow speed higher than 2 m/s assessed in cerebral arteries by transcranial doppler or a significant elevation of the mean arterial blood flow speed on two consecutive evaluations


Estimated Enrollment: 92
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aneurysmal Subarachnoid Hemorrhage
Each consecutive patient suffering from aneurysmal subarachnoid hemorrhage

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients suffering from acute aneurysmal subarachnoid haemorrhage. .
Criteria

Inclusion Criteria:

  • recent(< 24 h) aneurysmal subarachnoid hemorrhage
  • written informed consent obtained from the patient or from close relatives

Exclusion Criteria:

  • refusal to participate
  • Non-aneurysmal subarachnoid hemorrhage
  • aneurysmal subarachnoid hemorrhage with estimated date of bleeding > 24 h
  • Chronic heart failure
  • Chronic medication able to modify the plasmatic level of BNP
  • Pregnancy
  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): NCT01773200


Contacts
Contact: Sébastien Pili-Floury, MD, PhD +33 3 81 66 85 79 spilifloury@orange.fr

Locations
France
CHRU de Besançon Recruiting
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Sébastien Pili-Floury, MD, PhD CHRU de Besançon
  More Information

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01773200     History of Changes
Other Study ID Numbers: P/2012/153
First Submitted: January 18, 2013
First Posted: January 23, 2013
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Centre Hospitalier Universitaire de Besancon:
endothelial progenitor cells
aneurysmal subarachnoid hemorrhage
vasospasm
BNP

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases