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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00823485
First received: January 14, 2009
Last updated: December 8, 2011
Last verified: December 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • assessment of morbidity [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subarachnoid hemorrhage by aneurysm rupture
  • severe intraventricular hemorraghia

Exclusion Criteria:

  • pregnant women
  • hemostasis disturbance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823485

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

No publications provided by Centre Hospitalier Universitaire de Nice

Additional 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
Study First Received: January 14, 2009
Last Updated: December 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on September 29, 2014