Clinical trial NCT01773200: Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: endothelial progenitor cells
aneurysmal subarachnoid hemorrhage
vasospasm
BNP
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients suffering from acute aneurysmal subarachnoid haemorrhage. .

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: endothelial progenitor cells count
timeFrame: day 3 after bleeding
Secondary outcomes:
measure: Endothelial progenitor cells count
timeFrame: day 0, 6, 10, 14, 21 after bleeding
measure: Maximal amplitude of variation of EPC count
timeFrame: 3 weeks after bleeding
measure: Plasmatic brain natriuretic peptide
timeFrame: day 0, 3, 6, 10, 14, 21 after bleeding
Other outcomes:
measure: Glasgow Outcome Scale
timeFrame: One year after bleeding
measure: Vasospasm occurence
timeFrame: during the 3 weeks after bleeding
Locations:
city: Besançon
country: France
facility: CHRU de Besançon
Study officials:
affiliation: CHRU de Besançon
name: Sébastien Pili-Floury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: