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Trial record 80 of 195 for:    Hemorrhage AND SAH

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

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ClinicalTrials.gov Identifier: NCT02026596
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Aneurysmal Subarachnoid Hemorrhage Procedure: Magnetic resonance imaging Procedure: Cerebral microdialysis catheter insertion

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Observational Study on Mechanisms and Prevention of Secondary Brain Injury in Subarachnoid Haemorrhage
Study Start Date : March 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Neurological outcome of the patient [ Time Frame: 6 months ]
    Neurological outcome is evaluated with modified Rankin Scale at 6 months.


Biospecimen Description:
  • Blood samples
  • Cerebrospinal fluid samples
  • Microdialysate samples (from the extracellular fluid of the brain)
  • Tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from aneurysmal subarachnoid haemorrhage
Criteria

Inclusion Criteria:

  • aneurysmal subarachnoid haemorrhage

Exclusion Criteria:

  • age under 18 years
  • pregnant
  • moribund patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026596


Locations
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Finland
Tampere University Hospital
Tampere, Länsi-Suomen lääni, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital

Additional Information:

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02026596     History of Changes
Other Study ID Numbers: TampereUH
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by Tampere University Hospital:
subrachnoid hemorrhage
secondary brain injury

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Brain Injuries
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases