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

NCT00823485 — Phase 2 / Phase 3, Completed, 19 participants, Centre Hospitalier Universitaire de Nice
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RegistryNCT00823485
StatusCompleted
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, factorial, masking: single, treatment
Enrollment19 (Actual)
SponsorCentre Hospitalier Universitaire de Nice (Other)
ConditionsAneurysm, Ruptured, Subarachnoid Hemorrhage
Interventionsfibrinolysis in situ, drainage (Procedure)
Datesstart 2005-10-01, primary completion 2009-12-01, completion 2009-12-01, first posted 2009-01-15, last updated 2026-03-31
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Aneurysm, Ruptured All trials for Subarachnoid Hemorrhage All trials of fibrinolysis in situ All trials of drainage

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
2Active comparatorProcedure: drainagedrainage of hemorraghia
1ExperimentalProcedure: fibrinolysis in situActylise
  • fibrinolysis in situ (Procedure): intraventricular injection of actilyse
  • drainage (Procedure): drainage

+Outcome measures

Primary outcomes

  • assessment of mortality [at 30 days]

Secondary outcomes

  • assessment of morbidity [at 6 months]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* subarachnoid hemorrhage by aneurysm rupture
* severe intraventricular hemorraghia

Exclusion Criteria:

* pregnant women
* hemostasis disturbance

+Locations (1)

FacilityCityCountryStatus
Neurosurgery department , Nice University HospitalNiceFrance

+Publications

  • Results publication: 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. PMID 23636409