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Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823485
First Posted: January 15, 2009
Last Update Posted: December 9, 2011
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.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose
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.

Condition Intervention Phase
Aneurysm, Ruptured Subarachnoid Hemorrhage Procedure: fibrinolysis in situ Procedure: drainage Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • assessment of mortality [ Time Frame: at 30 days ]

Secondary Outcome Measures:
  • assessment of morbidity [ Time Frame: at 6 months ]

Enrollment: 19
Study Start Date: October 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
drainage of hemorraghia
Procedure: drainage
drainage
Experimental: 1
Actylise
Procedure: fibrinolysis in situ
intraventricular injection of actilyse

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subarachnoid hemorrhage by aneurysm rupture
  • severe intraventricular hemorraghia

Exclusion Criteria:

  • pregnant women
  • hemostasis disturbance
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00823485


Locations
France
Neurosurgery department , Nice University Hospital
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00823485     History of Changes
Other Study ID Numbers: 05-CIR-03
First Submitted: January 14, 2009
First Posted: January 15, 2009
Last Update Posted: December 9, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Hemorrhage
Aneurysm
Subarachnoid Hemorrhage
Rupture
Aneurysm, Ruptured
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries