Clinical trial NCT03985176: Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage
Official title: Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage: a Clinical Observational Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: aneurysmal subarachnoid hemorrhage
delayed cerebral ischemia
Intensive Care Unit
Neurosurgery
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from aneurysmal subarachnoid haemorrhage

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of delayed cerebral ischemia
timeFrame: 14 days
Secondary outcomes:
measure: Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis
timeFrame: at 72 hours
measure: Incidence of deep venous thrombosis
timeFrame: Within 3-7 days
measure: Other rotational thromboelastometry analysis
timeFrame: from 24 to 288 hours
measure: Assessment of neurological outcome
timeFrame: 90 days
measure: Assessment of pain
timeFrame: Up to 14 days
measure: Assessment of cardiopulmonary function by transthoracic echocardiography
timeFrame: At admission and at at 24±4 hours
measure: Continuous electroencephalography
timeFrame: From 48 hours to 14 days
measure: Neuroglial brain injury biomarkers
timeFrame: From 24 to 288 hours
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Simo Varila
role: STUDY_CHAIR
References: