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

Completed

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Alteplase Drug
    Intervention Desc: IV
  • Fibrinolysis in situ Procedure
    Intervention Desc: intraventricular injection of actilyse
    ARM 1: Kind: Experimental
    Label: 1
    Description: Actylise
  • Drainage Procedure
    Intervention Desc: drainage
    ARM 1: Kind: Experimental
    Label: 2
    Description: drainage of hemorraghia

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Factorial Assignment

Patient Involvement

Patients are randomized to either surgical drainage of hemorrhage or to receive Altepase IV.

Outcomes

Type Measure Time Frame Safety Issue
Primary Assessment of mortality.
Secondary Assessment of morbidity.
Primary assessment of mortality at 30 days Yes
Secondary assessment of morbidity at 6 months Yes

Sponsors