Multimodality Monitoring Directed Management of Aneurysmal Subarachnoid Haemorrhage

NCT03010709 | Unknown

• 1 other identifier: A094232
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aneurysmal subarachnoid haemorrhage (aSAH) affects up to 10,000 individuals per year in the UK. It accounts for \~5% of strokes, but is responsible for about 25% quality-adjusted life years (QALYs) lost due to stroke. Although early repair of ruptured aneurysms and aggressive postoperative management has improved overall outcomes, it remains a devastating disease with mortality approaching 50%. Survivors are left with neurological injuries that range from subtle cognitive deficit to disabling cerebral infarctions, less than 60% them returning to functional independence. SAH triggers a series of pathological processes resulting in neuronal damage and consequent neurological deficit termed early brain injury (EBI). Many of the patients who survive the initial bleed, deteriorate days later from delayed ischaemic neurological deficit (DIND), which causes poor outcome or death in up to 30% of patients with SAH. Both of these pathological processes are still poorly understood which limits the number of treatment options. DIND is treated with blood pressure augmentation to ensure adequate blood flow in the brain. In awake patients, response can be easily and accurately assessed by performing a thorough neurological examination. In patients whose clinical condition demands sedation, intubation and ventilation, assessing response to treatment using the neurological examination is virtually impossible. Multimodality monitoring (MM), primarily microdialysis and brain tissue oxygen tension with catheters inserted into the relevant parts of the brain offer direct assessment of both delivery and utilisation of metabolic substrates at the cellular level. These can be used for early detection of DIND as well as monitoring during blood pressure augmentation. The aim of this study is to establish and validate a clinical protocol for MM derived management of SAH patients, to determine optimal therapies for correcting abnormalities in brain metabolism and explore the relationship between MD and other monitoring modalities.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Aneurysmal Subarachnoid Haemorrhage; Delayed Ischaemic Neurological Deficit; Induced Hypertension; Partial Brain Tissue Oxygen Tension; Cerebral Microdialysis

Outcome Measures

Primary Outcomes (1)

• Improvement in brain tissue oxygen tension

  Brain Tissue Oxygen measured continuously on Neurointensive Care.

  10 days

Secondary Outcomes (2)

• Lactate to pyruvate ratio measured by microdialysis

  10 days

• Improved functional outcome of patients as measured by the validated and widely used Extended Glasgow Outcome Scale

  6 months

Eligibility Criteria

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

Study Population

Patient with aneurysmal subarachnoid haemorrhage who require intubation and ventilation and admission to the critical care unit.

You may qualify if:

• Aneurysmal Subarachnoid Haemorrhage
• Patient in Neurosciences Critical Care Unit
• Patient likely to survive for at least 24 hours

You may not qualify if:

• Patient unsuitable for microdialysis monitoring
• bleeding diathesis
• thrombocytopaenia (platelets \< 100 x 10e9 per litre)
• Non-survivable brain injury i.e. patient not expected to survive more than 24 hours

Sponsors & Collaborators

• Adel Helmy: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Microdialysates, cerebrospinal fluid and blood

MeSH Terms

Conditions

Subarachnoid Hemorrhage

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

Study Officials

• Adel Helmy, MBBChir PhD

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adel Helmy, MBBChir PhD

CONTACT

07855064515; adelhelmy@doctors.org.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 5, 2017
• Study Start: February 1, 2017
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share