SpareBrain - Mechanisms and Prevention of Secondary Brain Injury in Subarachnoid Haemorrhage

Completed

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Procedure: Magnetic resonance imaging; Procedure: Cerebral microdialysis catheter insertion

• Registration Number: NCT02026596
• Lead Sponsor: Tampere University Hospital

Brief Summary

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 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 limited understanding of the mechanisms of secondary insults causing brain injury after SAH.

In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.

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 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 limited understanding of the mechanisms of secondary insults causing brain injury after SAH.

In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2014-01-01
• Study First Posted: 2014-01-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• aneurysmal subarachnoid haemorrhage

Exclusion Criteria

• age under 18 years
• pregnant
• moribund patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
aSAH patients	Cerebral microdialysis catheter insertion	Patients suffering from aneurysmal subarachnoid haemorrhage
aSAH patients	Magnetic resonance imaging	Patients suffering from aneurysmal subarachnoid haemorrhage

Primary Outcome Measures

Name	Time	Method
Neuroradiologically confirmed secondary injury lesions	up to 2 weeks after the primary insult	Neuroradiological imaging (CT/MRI) is performed when clinically indicated and at 2 weeks after primary insult.

Secondary Outcome Measures

Name	Time	Method
Neurological outcome of the patient	6 months	Neurological outcome is evaluated with modified Rankin Scale at 6 months.

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Länsi-Suomen lääni, Finland