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

NCT02026596 | Completed DMC

• 1 other identifier: TampereUH
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

subrachnoid hemorrhage; secondary brain injury

Outcome Measures

Primary Outcomes (1)

• Neuroradiologically confirmed secondary injury lesions

  Neuroradiological imaging (CT/MRI) is performed when clinically indicated and at 2 weeks after primary insult.

  up to 2 weeks after the primary insult

Secondary Outcomes (1)

• Neurological outcome of the patient

  6 months

Study Arms (1)

aSAH patients

Patients suffering from aneurysmal subarachnoid haemorrhage

Procedure: Magnetic resonance imaging; Procedure: Cerebral microdialysis catheter insertion

Interventions

Magnetic resonance imaging PROCEDURE

aSAH patients

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.

aSAH patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from aneurysmal subarachnoid haemorrhage

You may qualify if:

• aneurysmal subarachnoid haemorrhage

You may not qualify if:

• age under 18 years
• pregnant
• moribund patient

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Länsi-Suomen Lääni, 33521, Finland

Location

Biospecimen

* Blood samples * Cerebrospinal fluid samples * Microdialysate samples (from the extracellular fluid of the brain) * Tissue samples

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: January 3, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

FI (1)