Subarachnoid Hemorrhage Clinical Trial
Official title:
Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage
Verified date | May 2016 |
Source | University Clinic Frankfurt |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational [Patient Registry] |
Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.
Status | Completed |
Enrollment | 173 |
Est. completion date | January 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - spontaneous, non-traumatic SAH - SAH confirmed on computed tomography (CT) or lumbar puncture - negative initial and follow-up angiography - age: no limit Exclusion Criteria: - traumatic SAH - aneurysmal SAH - SAH in whom other bleeding sources were identified (AVM etc.) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Clinic Frankfurt |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 | Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 stratified to: non-aneurysmal SAH PM /NPM-SAH mRS 0 group NPM-SAH: Fisher 3 or non-Fisher 3 bleeding pattern |
18months to 15 years | No |
Secondary | mortality | deaths until long-term follow-up | 18months to 15 years | No |
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