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

January 14, 2009
December 8, 2011
October 2005
December 2009   (final data collection date for primary outcome measure)
assessment of mortality [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00823485 on ClinicalTrials.gov Archive Site
assessment of morbidity [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture
Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Aneurysm, Ruptured
  • Subarachnoid Hemorrhage
  • Procedure: fibrinolysis in situ
    intraventricular injection of actilyse
  • Procedure: drainage
    drainage
  • Active Comparator: 2
    drainage of hemorraghia
    Intervention: Procedure: drainage
  • Experimental: 1
    Actylise
    Intervention: Procedure: fibrinolysis in situ
Litrico S, Almairac F, Gaberel T, Ramakrishna R, Fontaine D, Sedat J, Lonjon M, Paquis P. Intraventricular fibrinolysis for severe aneurysmal intraventricular hemorrhage: a randomized controlled trial and meta-analysis. Neurosurg Rev. 2013 Oct;36(4):523-30; discussion 530-1. doi: 10.1007/s10143-013-0469-7. Epub 2013 May 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • subarachnoid hemorrhage by aneurysm rupture
  • severe intraventricular hemorraghia

Exclusion Criteria:

  • pregnant women
  • hemostasis disturbance
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00823485
05-CIR-03
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP