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

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ClinicalTrials.gov Identifier: NCT00823485
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : December 9, 2011
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Tears

Arm Intervention/treatment
Active Comparator: 2
drainage of hemorraghia
Procedure: drainage
drainage

Experimental: 1
Actylise
Procedure: fibrinolysis in situ
intraventricular injection of actilyse




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: January 15, 2009    Key Record Dates
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