ew laboratory parameters for the detection of stroke-related complications after rupture of an intracranial aneurysm: role of small cell membrane fragments in the blood and cerebrospinal fluid

Completed

Conditions: Aneurysmal subarachnoid hemorrhage/neurocritical care
Nervous System Diseases
Subarachnoid haemorrhage

Registration Number: ISRCTN82221453

Lead Sponsor: Austrian Science Fund (FWF) (Austria)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 63

Inclusion Criteria

1. Patients of either sex aged between 18?75 years
2. Signs and symptoms of SAH with an onset within 48 hours before screening irrespective of World Federation of Neurological Surgeons (WFNS) grade (I?V) at admission
3. A computed tomography (CT) scan shows an aneurysmal bleeding pattern in combination with the presence of an appropriate aneurysm at CT angiography or digital subtraction angiography (DSA)
4. Women of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria

1. Definite contraindication to magnetic resonance imaging (MRI) (e.g., pacemakers)
2. History of trauma, cerebral vascular malformation or other non-aneurysmal source of bleeding
3. Moderate to severe cerebral vasospasm at screening
4. Known coagulopathies, long-term therapy with platelet aggregation inhibitors or oral anticoagulants
5. Severe concomitant diseases as well as patients in whom death seems imminent

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic value of cellular microparticles for the occurrence of cerebral infarction attributable to delayed cerebral ischemia (i.e., not adjudicated to lesions arising from the aneurysm repair procedure, intracerebral hemorrhage or ventricular drain encephalomalacia) assessed by magnetic resonance imaging (MRI) at day 21 ± 2.

Secondary Outcome Measures

Name	Time	Method
Association of cellular microparticles with patient morbidity and mortality at the 3-month follow-up visit. Other (exploratory) endopoints, derived from the clinical database, might be analyzed on data-driven considerations.