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NCT Number: NCT02026596

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

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.

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, Länsi-Suomen Lääni, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aneurysmal subarachnoid haemorrhage

Exclusion criteria

  • age under 18 years
  • pregnant
  • moribund patient

Treatment and study plan

Magnetic Resonance Imaging

Procedure

Cerebral microdialysis catheter insertion

Procedure

Is inserted only when invasive intracranial pressure monitoring is required. The same route with pressure probe is used for insertion.

Primary outcomes

  1. Neuroradiologically confirmed secondary injury lesions

    Time frame: 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 outcomes

  1. Neurological outcome of the patient

    Time frame: 6 months

    Neurological outcome is evaluated with modified Rankin Scale at 6 months.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

Observational Study on Mechanisms and Prevention of Secondary Brain Injury in Subarachnoid Haemorrhage

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 3, 2014
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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