Aneurysmal Subarachnoid Hemorrhage
Conditions
Keywords
aneurysmal subarachnoid hemorrhage, delayed cerebral ischemia, Intensive Care Unit, Neurosurgery
Brief summary
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI). In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.
Detailed description
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from a secondary injury during the first 2-3 weeks from the insult. Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI). In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.
Interventions
DEVICEROTEM
ROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH
PROCEDUREEEG
Continuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH
PROCEDUREbilateral compression ultrasound of the lower extremity veins
to exclude asymptomatic deep venous thrombosis once over days 3 to 7
Sponsors
Tampere University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Admitted to the Tampere University Hospital ICU due to aneurysmal SAH * Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA) * Definite or approximated time for the onset of symptoms and delay to ICU admission no more than 24 hours * Expected treatment time at least 120 hours in the Tampere University Hospital
Exclusion criteria
* Known pregnancy * Any long-term anticoagulant or antithrombotic medication, except for low-dose aspirin (under 150 mg/day) * Known active cancer or cirrhotic liver disease or end-stage renal disease requiring renal replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delayed cerebral ischemia | 14 days | Incidence of DCI (delayed cerebral ischemia) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of deep venous thrombosis | Within 3-7 days | Incidence of deep venous thrombosis |
| Other rotational thromboelastometry analysis | from 24 to 288 hours | Maximal clot firmness of extrinsic (EXTEM) analysis (EXTEM-MCF) using rotational thromboelastometry |
| Assessment of neurological outcome | 90 days | Description of the neurological outcome by using extended Glasgow Outcome Score 1. Death 2. Vegetative sate 3. Lower severe disability 4. Upper severe disability 5. Lower moderate disability 6. Upper moderate disability 7. Lower good recovery 8. Upper good recovery |
| Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis | at 72 hours | Maximal clot firmness of FIBTEM analysis (FIBTEM-MCF) using rotational thromboelastometry (ROTEM) assay |
| Assessment of cardiopulmonary function by transthoracic echocardiography | At admission and at at 24±4 hours | Function of the left and right ventricle using scale 1. hyperkinetic,2. normal, 3. moderately impaired, 4. severely impaired |
| Continuous electroencephalography | From 48 hours to 14 days | Continuous electroencephalography will be evaluated for signs that are potential surrogates of developing delayed cerebral ischemia (such as alpha-delta-ratio, focal slowing, epileptiform abnormalities, relative alpha variability) |
| Neuroglial brain injury biomarkers | From 24 to 288 hours | Peripheral blood biomarkers potentially reflecting neuroglial injury will be analysed with enzyme-linked immunosorbent assays |
| Assessment of pain | Up to 14 days | Critical Care Pain Observation Tool values, from 0: no pain to 8: maximum pain |
Countries
Finland
Outcome results
None listed