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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026596
• Other study ID #: TampereUH
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: October 30, 2017
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aneurysmal subarachnoid haemorrhage

Exclusion Criteria:

• age under 18 years

• pregnant

• moribund patient

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Brain Injuries
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Procedure:
• Magnetic resonance imaging

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere	Länsi-Suomen lääni

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neurological outcome of the patient	Neurological outcome is evaluated with modified Rankin Scale at 6 months.	6 months