Aneurysmal subarachnoid haemorrhage (aSAH) Circulatory System Subarachnoid haemorrhage
Conditions
Interventions
Screening begins when a patient (less than 72 hours post-rupture of aneurysm) is seen in the emergency room (aneurysm treatment within 24 hours). If patient is eligible, electrode strip (Wyler, 5-mm d
Ad-Tech Medical, Racine, Wisconsin, USA) for cortical spreading depolarisation (CSD) monitoring, oxygen/temperature sensor (Licox, Integra Lifesciences Corporation, Plainsboro, NJ, USA) and microdialy
Sponsors
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/08/2011: 1. Male or female patients aged 18 or older (inclusive) 2. World Federation of Neurosurgery (WFNS) grade I ? V unless the clinical state suggests an unfavourable prognosis such as wide, non-reactive pupils for more than 1h 3. Ruptured saccular aneurysm demonstrated by CT-angiography or digital subtraction angiography (DSA) 4. Onset of aSAH clinical symptoms within the preceding 72 hours 5. Treatment of aneurysm (clip ligation or endovascular coil embolisation) 6. Indication for a ventricular drain or oxygen sensor in coiled patients 7. Informed consent is obtained from the patient or a legal representative Previous inclusion criteria: 1. Male or female patients aged 18 to 70 years (inclusive) 2. World Federation of Neurosurgery (WFNS) grade III - IV, and grade V patients who improve within 24 hours after ventriculostomy 3. Diffuse thick or localised thick subarachnoid clot on baseline computerised tomography (CT) 4. Ruptured saccular aneurysm demonstrated by CT-angiography or digital subtraction angiography (DSA) 5. Onset of aSAH clinical symptoms within the preceding 72 hours 6. Treatment of aneurysm (clip ligation or endovascular coil embolisation) 7. Indication for a ventricular drain in coiled patients 8. Informed consent is obtained from the patient or a legal representative
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/08/2011: 1. ASAH due to other causes (e.g., trauma, fusiform or mycotic aneurysm) 2. Admission in a clinical state with unfavourable prognosis (e.g., wide, nonreactive pupils for more than 1 hour) 3. Bleeding diasthesis 4. Cytostatic therapy in patients with malignant disease 5. Pregnancy 6. Special exclusion criteria for MRI such as non-MRI-compatible, non-removable metals, artificial joints etc., electronic devices (pacemaker, pumps etc.) 7. Interruption of monitoring for more than 48h during days 3-5, or 24h during days 6-8 or 24h during days 9-11 unless the patient dies after day 5 or develops an MRI documented delayed ischemic stroke during the monitoring period and recording is only interrupted after those events 8. Respiratory/haemodynamic instability does not allow MR transport (i.e. transport of the patient to the magentic resonance tomogram, patient monitoring during imaging, transport back to the ward) Previous exclusion criteria: 1. ASAH due to other causes (e.g., trauma, fusiform or mycotic aneurysm) 2. Only a thin diffuse layer or no visible subarachnoid blood in the initial CT 3. Admission in a clinical state with unfavourable prognosis (e.g., wide, nonreactive pupils for more than 1 hour) 4. Significant disturbance of coagulation (thrombocytes less than 60/nl, quick value less than 60%, partial thromboplastin time greater than 45 seconds) 5. Cytostatic therapy in patients with malignant disease 6. Pregnancy 7. Special exclusion criteria for MRI such as non-removable metals, artificial joints etc., electronic devices (pacemaker, pumps etc.) 8. Interruption of monitoring for more than 24 hours during days 4 - 6 or days 7 - 9 9. Respiratory/haemodynamic instability does not allow MR transport (i.e. transport of the patient to the magentic resonance tomogram, patient monitoring during imaging, transport back to the ward)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of a new delayed ischaemia infarct (comparison between MRI 48 hours after event and MRI 15 days after event). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Location of a new delayed ischaemic infarct in the recording area, ipsilateral lobe adjacent to electrode strip, ipsilateral hemisphere and whole brain (comparison of MRI1 and MRI3). Total duration of follow-up: 6 months. 2. In unsedated patients, occurrence of clinical delayed ischaemic neurological deficit (DIND) defined by delayed decrease of consciousness (greater than or equal to 2 Glasgow Coma Scale [GCS] levels) and/or new focal neurological deficit with onset between 48 hours and 14 days after aSAH and at least 24 hours following surgery or coiling that cannot be attributed to rebleeding, systemic or post-operative complications, or hydrocephalus 3. Death related to delayed ischaemic infarcts/death of other causes. Total duration of follow-up: 6 months. 4. Clinical outcome on day 15 post-aSAH (mRS) and at 6 months (modified Rankin scale [mRS], Glasgow Outcome Score-Extended [GOSE]) | — |
Countries
Germany
Outcome results
None listed