Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage (EVAPROPEC)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01773200|
Recruitment Status : Unknown
Verified March 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was: Recruiting
First Posted : January 23, 2013
Last Update Posted : March 31, 2016
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 or disease|
|Aneurysmal Subarachnoid Hemorrhage|
|Study Type :||Observational|
|Estimated Enrollment :||92 participants|
|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 Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Aneurysmal Subarachnoid Hemorrhage
Each consecutive patient suffering from aneurysmal subarachnoid hemorrhage
- endothelial progenitor cells count [ Time Frame: day 3 after bleeding ]
- 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 ]
- 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
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
|Contact: Sébastien Pili-Floury, MD, PhD||+33 3 81 66 85 email@example.com|
|CHRU de Besançon||Recruiting|
|Besançon, France, 25000|
|Principal Investigator:||Sébastien Pili-Floury, MD, PhD||CHRU de Besançon|