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

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT00823485
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysm, Ruptured; Subarachnoid Hemorrhage	Procedure: fibrinolysis in situ; Procedure: drainage	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 drainage of hemorraghia	Procedure: drainage; drainage
Experimental: 1 Actylise	Procedure: fibrinolysis in situ; intraventricular injection of actilyse

Outcome Measures

Primary Outcome Measures

1. assessment of mortality [at 30 days]

Secondary Outcome Measures

1. assessment of morbidity [at 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• subarachnoid hemorrhage by aneurysm rupture

• severe intraventricular hemorraghia

Exclusion Criteria:

• pregnant women

• hemostasis disturbance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurosurgery department , Nice University Hospital	Nice		France	06000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT00823485
• Other Study ID Numbers: 05-CIR-03
• First Posted: Jan 15, 2009
• Last Update Posted: Dec 9, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Aneurysm; Aneurysm, Ruptured; Hemorrhage; Rupture

Study Results

No Results Posted as of Dec 9, 2011