Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

NCT ID: NCT03985176

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2025-12-31

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Aneurysmal SAH patients

Patients suffering from aneurysmal subarachnoid haemorrhage

ROTEM

Intervention Type: DEVICE

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

EEG

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

to exclude asymptomatic deep venous thrombosis once over days 3 to 7

Interventions

ROTEM

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

Intervention Type: DEVICE

EEG

Continuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH

Intervention Type: PROCEDURE

bilateral compression ultrasound of the lower extremity veins

to exclude asymptomatic deep venous thrombosis once over days 3 to 7

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simo Varila

Role: STUDY_CHAIR

Tampere University Hospital

Locations

Tampere University Hospital

Tampere, , Finland

Countries

Finland

References

Raatikainen E, Kiiski H, Kuitunen A, Junttila E, Huhtala H, Kallonen A, Ala-Peijari M, Langsjo J, Saukkonen J, Valo T, Kauppila T, Raerinne S, Frosen J, Vahtera A. Increased blood coagulation is associated with poor neurological outcome in aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2024 Mar 15;458:122943. doi: 10.1016/j.jns.2024.122943. Epub 2024 Feb 23.

Reference Type: DERIVED

PMID: 38422781 (View on PubMed)

Other Identifiers

R18110

Identifier Type: -

Identifier Source: org_study_id