- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823485
Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture
December 8, 2011 updated by: Centre Hospitalier Universitaire de Nice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nice, France, 06000
- Neurosurgery department , Nice University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- subarachnoid hemorrhage by aneurysm rupture
- severe intraventricular hemorraghia
Exclusion Criteria:
- pregnant women
- hemostasis disturbance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
drainage of hemorraghia
|
drainage
|
Experimental: 1
Actylise
|
intraventricular injection of actilyse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
assessment of mortality
Time Frame: at 30 days
|
at 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
assessment of morbidity
Time Frame: at 6 months
|
at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 14, 2009
First Submitted That Met QC Criteria
January 14, 2009
First Posted (Estimate)
January 15, 2009
Study Record Updates
Last Update Posted (Estimate)
December 9, 2011
Last Update Submitted That Met QC Criteria
December 8, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-CIR-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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