Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

Tampere University Hospital

Status: Active, not recruiting

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Procedure: bilateral compression ultrasound of the lower extremity veins; Device: ROTEM; Procedure: EEG

Study type: Observational

Funder types: Other

Identifiers

NCT03985176

R18110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

62 participants in 1 patient group

Aneurysmal SAH patients

Description:

Patients suffering from aneurysmal subarachnoid haemorrhage

Treatment:

Procedure: EEG

Device: ROTEM

Procedure: bilateral compression ultrasound of the lower extremity veins