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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Aneurysmal Subarachnoid Hemorrhage

• Study Type: Observational
• Enrollment (Anticipated): 92

Contacts and Locations

• Study Contact: Name: Sébastien Pili-Floury, MD, PhD; Phone Number: +33 3 81 66 85 79; Email: spilifloury@orange.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHRU De Besancon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients suffering from acute aneurysmal subarachnoid haemorrhage. .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Aneurysmal Subarachnoid Hemorrhage; Each consecutive patient suffering from aneurysmal subarachnoid hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
endothelial progenitor cells count	day 3 after bleeding

Secondary Outcome Measures

Outcome Measure	Time Frame
Endothelial progenitor cells count	day 0, 6, 10, 14, 21 after bleeding
Maximal amplitude of variation of EPC count	3 weeks after bleeding
Plasmatic brain natriuretic peptide	day 0, 3, 6, 10, 14, 21 after bleeding

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Outcome Scale		One year after bleeding
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Sébastien Pili-Floury, MD, PhD, CHRU De Besancon

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: January 18, 2013
• First Submitted That Met QC Criteria: January 22, 2013
• First Posted (ESTIMATE): January 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: vasospasm; BNP; endothelial progenitor cells; aneurysmal subarachnoid hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: P/2012/153