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

NCT ID: NCT00823485

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aneurysm, Ruptured Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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2

drainage of hemorraghia

Group Type ACTIVE_COMPARATOR

drainage

Intervention Type PROCEDURE

drainage

1

Actylise

Group Type EXPERIMENTAL

fibrinolysis in situ

Intervention Type PROCEDURE

intraventricular injection of actilyse

Interventions

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fibrinolysis in situ

intraventricular injection of actilyse

Intervention Type PROCEDURE

drainage

drainage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* subarachnoid hemorrhage by aneurysm rupture
* severe intraventricular hemorraghia

Exclusion Criteria

* pregnant women
* hemostasis disturbance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neurosurgery department , Nice University Hospital

Nice, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 23636409 (View on PubMed)

Other Identifiers

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05-CIR-03

Identifier Type: -

Identifier Source: org_study_id