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CompletedNCT00823485Updated Mar 31, 2026

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

A Phase 2/3 interventional study of fibrinolysis in situ and drainage in Aneurysm, Ruptured and Subarachnoid Hemorrhage, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aneurysm, Ruptured
  • Subarachnoid Hemorrhage
03

In context

Aneurysm, Ruptured

29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.

This study's enrollment of 19 is below the median of 33 across 16 interventional studies indexed under Aneurysm, Ruptured.

Browse Aneurysm, Ruptured studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Browse Centre Hospitalier Universitaire de Nice studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • subarachnoid hemorrhage by aneurysm rupture
  • severe intraventricular hemorraghia

Exclusion criteria

Exclusion Criteria:

  • pregnant women
  • hemostasis disturbance
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    2

    drainage of hemorraghia

    Procedure: drainage

  • Experimental
    1

    Actylise

    Procedure: fibrinolysis in situ

Interventions

  • Procedurefibrinolysis in situ

    intraventricular injection of actilyse

  • Proceduredrainage

    drainage

06

What researchers measure

Primary outcomes

  1. assessment of mortality

    Time frame: at 30 days

Secondary outcomes

  1. assessment of morbidity

    Time frame: at 6 months

07

Study locations

1 site
  • Neurosurgery department , Nice University Hospital
    Nice, 06000, France
08

References and documents

Publications

  • 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. PubMed 23636409 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2005, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2009
First posted
Jan 15, 2009
Start
Oct 2005
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Last update
Mar 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00823485
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jan 15, 2009
Start date
Oct 2005
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 31, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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