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

October 30, 2017 updated by: Tampere University Hospital

Observational Study on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Länsi-Suomen lääni
      • Tampere, Länsi-Suomen lääni, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from aneurysmal subarachnoid haemorrhage

Description

Inclusion Criteria:

  • aneurysmal subarachnoid haemorrhage

Exclusion Criteria:

  • age under 18 years
  • pregnant
  • moribund patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
aSAH patients
Patients suffering from aneurysmal subarachnoid haemorrhage
Procedure: Magnetic resonance imaging
Procedure: Cerebral microdialysis catheter insertion
Is inserted only when invasive intracranial pressure monitoring is required. The same route with pressure probe is used for insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 2 weeks after the primary insult

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological outcome of the patient
Time Frame: 6 months
Neurological outcome is evaluated with modified Rankin Scale at 6 months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

January 1, 2014

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TampereUH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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