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Trial record 99 of 195 for:    Hemorrhage AND SAH

Multimodality Monitoring Directed Management of Aneurysmal Subarachnoid Haemorrhage (MMMSAH)

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ClinicalTrials.gov Identifier: NCT03010709
Recruitment Status : Not yet recruiting
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Adel Helmy, University of Cambridge

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.


Condition or disease
Subarachnoid Hemorrhage, Aneurysmal

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodality Monitoring Directed Management of Aneurysmal Subarachnoid Haemorrhage
Study Start Date : February 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Improvement in brain tissue oxygen tension [ Time Frame: 10 days ]
    Brain Tissue Oxygen measured continuously on Neurointensive Care.


Secondary Outcome Measures :
  1. Lactate to pyruvate ratio measured by microdialysis [ Time Frame: 10 days ]
    Microdialysis measured LP ratio measured hourly on Neurointensive Care.

  2. Improved functional outcome of patients as measured by the validated and widely used Extended Glasgow Outcome Scale [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Microdialysates, cerebrospinal fluid and blood


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with aneurysmal subarachnoid haemorrhage who require intubation and ventilation and admission to the critical care unit.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient unsuitable for microdialysis monitoring

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

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): NCT03010709


Contacts
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Contact: Adel Helmy, MBBChir PhD 07855064515 adelhelmy@doctors.org.uk

Sponsors and Collaborators
Adel Helmy
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Adel Helmy, MBBChir PhD Cambridge University Hospitals NHS Foundation Trust

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Responsible Party: Adel Helmy, Principal Investigator, University of Cambridge
ClinicalTrials.gov Identifier: NCT03010709     History of Changes
Other Study ID Numbers: A094232
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Adel Helmy, University of Cambridge:
Aneurysmal Subarachnoid Haemorrhage
Delayed Ischaemic Neurological Deficit
Induced Hypertension
Partial Brain Tissue Oxygen Tension
Cerebral Microdialysis

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases