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

Primary Purpose

Aneurysm, Ruptured, Subarachnoid Hemorrhage

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

fibrinolysis in situ

drainage

About this trial

This is an interventional treatment trial for Aneurysm, Ruptured

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

subarachnoid hemorrhage by aneurysm rupture
severe intraventricular hemorraghia

Exclusion Criteria:

pregnant women
hemostasis disturbance

Sites / Locations

Neurosurgery department , Nice University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

drainage of hemorraghia

Actylise

Outcomes

Primary Outcome Measures

assessment of mortality

Secondary Outcome Measures

assessment of morbidity

Full Information

NCT ID

NCT00823485

First Posted

January 14, 2009

Last Updated

December 8, 2011

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT00823485

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aneurysm, Ruptured, Subarachnoid Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

drainage of hemorraghia

Arm Title

Arm Type

Experimental

Arm Description

Actylise

Intervention Type

Procedure

Intervention Name(s)

fibrinolysis in situ

Intervention Description

intraventricular injection of actilyse

Intervention Type

Procedure

Intervention Name(s)

drainage

Intervention Description

drainage

Primary Outcome Measure Information:

Title

assessment of mortality

Time Frame

at 30 days

Secondary Outcome Measure Information:

Title

assessment of morbidity

Time Frame

at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: subarachnoid hemorrhage by aneurysm rupture severe intraventricular hemorraghia Exclusion Criteria: pregnant women hemostasis disturbance

Facility Information:

Facility Name

Neurosurgery department , Nice University Hospital

City

Nice

ZIP/Postal Code

06000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

23636409

Citation

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.

Results Reference

derived

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

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