Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage

NCT01773200 | Unknown

• 1 other identifier: P/2012/153
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

endothelial progenitor cells; aneurysmal subarachnoid hemorrhage; vasospasm; BNP

Outcome Measures

Primary Outcomes (1)

• endothelial progenitor cells count

  day 3 after bleeding

Secondary Outcomes (3)

• 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 Outcomes (2)

• Glasgow Outcome Scale

  One year after bleeding

• Vasospasm occurence

  during the 3 weeks after bleeding

Study Arms (1)

Aneurysmal Subarachnoid Hemorrhage

Each consecutive patient suffering from aneurysmal subarachnoid hemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients suffering from acute aneurysmal subarachnoid haemorrhage. .

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHRU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien Pili-Floury, MD, PhD

  CHRU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Pili-Floury, MD, PhD

CONTACT

+33 3 81 66 85 79; spilifloury@orange.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 23, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

FR (1)