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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00823485
Other study ID # 05-CIR-03
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received January 14, 2009
Last updated December 8, 2011
Start date October 2005
Est. completion date December 2009

Study information

Verified date December 2011
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality at 30 days in case of subarachnoid hemorrhage.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- subarachnoid hemorrhage by aneurysm rupture

- severe intraventricular hemorraghia

Exclusion Criteria:

- pregnant women

- hemostasis disturbance

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
fibrinolysis in situ
intraventricular injection of actilyse
drainage
drainage

Locations

Country Name City State
France Neurosurgery department , Nice University Hospital Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary assessment of mortality at 30 days Yes
Secondary assessment of morbidity at 6 months Yes
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