Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage: a Clinical Observational Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03985176
• Other study ID #: R18110
• Status: Active, not recruiting
• Start date: June 10, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Brain Ischemia
• Cerebral Infarction
• Hemorrhage
• Ischemia
• Subarachnoid Hemorrhage

Intervention

Device:
• ROTEM
ROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH

Procedure:
• EEG
Continuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH
• bilateral compression ultrasound of the lower extremity veins
to exclude asymptomatic deep venous thrombosis once over days 3 to 7

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delayed cerebral ischemia	Incidence of DCI (delayed cerebral ischemia)	14 days
Secondary	Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis	Maximal clot firmness of FIBTEM analysis (FIBTEM-MCF) using rotational thromboelastometry (ROTEM) assay	at 72 hours
Secondary	Incidence of deep venous thrombosis	Incidence of deep venous thrombosis	Within 3-7 days
Secondary	Other rotational thromboelastometry analysis	Maximal clot firmness of extrinsic (EXTEM) analysis (EXTEM-MCF) using rotational thromboelastometry	from 24 to 288 hours
Secondary	Assessment of neurological outcome	Description of the neurological outcome by using extended Glasgow Outcome Score; Death; Vegetative sate; Lower severe disability; Upper severe disability; Lower moderate disability; Upper moderate disability; Lower good recovery; Upper good recovery	90 days
Secondary	Assessment of pain	Critical Care Pain Observation Tool values, from 0: no pain to 8: maximum pain	Up to 14 days
Secondary	Assessment of cardiopulmonary function by transthoracic echocardiography	Function of the left and right ventricle using scale 1. hyperkinetic,2. normal, 3. moderately impaired, 4. severely impaired	At admission and at at 24±4 hours
Secondary	Continuous electroencephalography	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)	From 48 hours to 14 days
Secondary	Neuroglial brain injury biomarkers	Peripheral blood biomarkers potentially reflecting neuroglial injury will be analysed with enzyme-linked immunosorbent assays	From 24 to 288 hours