Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— EVAPROPEC  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01773200
• Other study ID #: P/2012/153
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2013
• Last updated: May 21, 2014
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2012
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Sébastien Pili-Floury, MD, PhD
• Phone: +33 3 81 66 85 79
• Email: spilifloury[@]orange.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
France	CHRU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glasgow Outcome Scale		One year after bleeding	No
Other	Vasospasm occurence	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	during the 3 weeks after bleeding	No
Primary	endothelial progenitor cells count		day 3 after bleeding	No
Secondary	Endothelial progenitor cells count		day 0, 6, 10, 14, 21 after bleeding	No
Secondary	Maximal amplitude of variation of EPC count		3 weeks after bleeding	No
Secondary	Plasmatic brain natriuretic peptide		day 0, 3, 6, 10, 14, 21 after bleeding	No