Neuroprotection in Aneurysmal Subarachnoid Hemorrhage - from Laboratory to Clinical Practice

Neuroprotection in Aneurysmal Subarachnoid Hemorrhage - from Laboratory to Clinical Practice - Neuroprotection in SAH - from Laboratory to Clinical Practice

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29768

Enrollment

100

Registered

2006-11-21

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subarachnoid hemorrhage

Interventions

Betaferon 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution, to be injected subcutaneously every other day for 14 days.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: aneurysmal subarachnoid hemorrhage

Exclusion criteria

Exclusion criteria: - non-aneurysmal causes of subarachnoid hemorrhage - pregnancy - use of interferon - a history of hypersensitivity to natural or recombinant interferon - severe depression and/or suicidal ideation - decompensated liver disease.

Design outcomes

Primary

Measure	Time frame
- relatie between studymedicatie and complicatiions	—

Secondary

Measure	Time frame
- serum TNF alfa - the occurrence of DCI within three months after onset of SAH and poor outcome after three months. DCI is defined as the occurrence of a new spontaneous hypodense lesion as revealed by a CT scan compatible with clinical features of DCI (gradually developed focal deficits, decreased level of consciousness, or both). Three months after the SAH we assess functional outcome with the modified Rankin scale, a 6-point handicap scale that focuses on restrictions in lifestyle, by means of a telephone interview.	—

Measure

Time frame

- serum TNF alfa - the occurrence of DCI within three months after onset of SAH and poor outcome after three months. DCI is defined as the occurrence of a new spontaneous hypodense lesion as revealed by a CT scan compatible with clinical features of DCI (gradually developed focal deficits, decreased level of consciousness, or both). Three months after the SAH we assess functional outcome with the modified Rankin scale, a 6-point handicap scale that focuses on restrictions in lifestyle, by means of a telephone interview.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)