NCT00823485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

January 14, 2009

Last Update Submit

March 26, 2026

Conditions

Aneurysm, RupturedSubarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • assessment of mortality

    at 30 days

Secondary Outcomes (1)

  • assessment of morbidity

    at 6 months

Study Arms (2)

2

ACTIVE COMPARATOR

drainage of hemorraghia

Procedure: drainage

1

EXPERIMENTAL

Actylise

Procedure: fibrinolysis in situ

Interventions

fibrinolysis in situPROCEDURE

intraventricular injection of actilyse

1
drainagePROCEDURE

drainage

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subarachnoid hemorrhage by aneurysm rupture
  • severe intraventricular hemorraghia

You may not qualify if:

  • pregnant women
  • hemostasis disturbance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurosurgery department , Nice University Hospital

Nice, 06000, France

Location

Related Publications (1)

  • 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: 23636409RESULT

MeSH Terms

Conditions

Aneurysm, RupturedSubarachnoid Hemorrhage

Interventions

FibrinolysisDrainage

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood CoagulationHemostasisBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

October 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)