Clinical Efficacy of In-situ Thrombolysis in Case of Intr... | NCT00823485

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

NCT00823485

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Mar 31, 2026Actual

Enrollment

19Actual

Phase

Phase 2Phase 3

Conditions

Aneurysm, Ruptured
Subarachnoid Hemorrhage

Interventions

fibrinolysis in situ
drainage

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jan 14, 2009

First Submission Date that Met QC Criteria

Jan 14, 2009

First Posted Date

Jan 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Mar 31, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator	drainage of hemorraghia	Procedure: drainage
1	Experimental	Actylise	Procedure: fibrinolysis in situ

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fibrinolysis in situ	Procedure	intraventricular injection of actilyse	1

Measure	Description	Time Frame
assessment of mortality		at 30 days

Measure	Description	Time Frame
assessment of morbidity		at 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subarachnoid hemorrhage by aneurysm rupture
severe intraventricular hemorraghia

Exclusion Criteria:

pregnant women
hemostasis disturbance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurosurgery department , Nice University Hospital		Nice		06000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23636409	Result	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.

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D020300	Intracranial Hemorrhages

ID	Term
D005342	Fibrinolysis
D004322	Drainage

ID	Term
D001777	Blood Coagulation
D006487	Hemostasis
D001790	Blood Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

ID	Term
D017542	Aneurysm, Ruptured
D013345	Subarachnoid Hemorrhage