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Evaluation of the Level and Prognostic Relevance of New Neuroinflammation Markers in Subarachnoid Haemorrhage (ESA-MICROPN)

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ClinicalTrials.gov Identifier: NCT03411746
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Rosanna Vaschetto, MD, PhD, Azienda Ospedaliero Universitaria Maggiore della Carita

Brief Summary:

Subarachnoid hemorrhage (SAH) consists of blood extravasation into the space between arachnoid and pia mater. Bleeding is a consequence of cerebral aneurysm rupture in most cases. Despite incidence being only 9 cases out of 1000 people per year, young age and high mortality and morbidity lead to loosing several years of healthy life. Therapy priorities are: preventing rebleeding, with endovascular treatment (when possible) or neurosurgical aneurism clipping; preventing complications associated with blood extravasation into subarachnoid pace, such as acute hydrocephalus treatment (that occurs in 20% of patients), by ventricular external drainage positioning, and delayed cerebral ischemia, mainly due to vasospasm, by endovenous administration of nimodipine; optimal perfusion pressure maintenance.

Endogenous osteopontin (OPN) is thought to fulfill a protective activity over ischemic damage both in brain and other organs, including kidney. Besides, recombinant OPN administration markedly decreases ischemic area in a focal cerebral ischemia model, by an antiapoptotic action. Recent in vivo studies on animal models of SAH demonstrated that OPN plays a major role: treatment with OPN seems to prevent vasospasm reducing smooth muscle cells and endothelial cells apoptosis.

Microparticles are mediators released by platelets, leucocytes, erythrocyte and endothelial cells. In ischemic stroke endothelial microparticles levels directly relate to clinical severity and ischemic area extension. In typical parenchymal haemorrhage microparticles levels are higher both in blood and in liquor and associated with worse clinical outcome. In SAH increased microparticle levels have been demonstrated, especially in the days of the bleeding, and microparticle levels change based on subtypes. Data disagree about the subtypes involved and their time course. This study aims to evaluate the correlation between OPN and microparticles levels and vasospasm development/ischemic lesion at the CT-scan, and subsequently with medium and long-term patients outcome.


Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Other: Subarachnoid haemorrhage

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of New Neuroinflammation Markers in Subarachnoid Haemorrhage Patients: a Pilot Study
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding


Intervention Details:
  • Other: Subarachnoid haemorrhage
    Data on the type of patients enrolled have been described already in other sections.


Primary Outcome Measures :
  1. Correlation between OPN and microparticle levels and vasospasm development/ischemic lesion at the CT-scan, and subsequently with medium and long-term patients outcome. [ Time Frame: Day 7 is the day expected for cerebral vasospasm. Therefore for the correlation between OPN/microparticles and vasospasm/ischemic lesion at CT scan will be evaluated on day 7. ]

    The levels of OPN and microparticles will be related to:

    1. the presence or absence of vasospasm development
    2. the presence or absence of ischemic lesion at the CT-scan
    3. 3-6 months outcome evaluated with the GOS-E


Secondary Outcome Measures :
  1. In vitro stimulation of renal and pulmonary endothelial cells with microparticles [ Time Frame: Microparticles isolated from patient blood on the day of the expected maximum release, i.e., day 7 will be incubated in vitro with renal and pulmonary endothelial cells. ]
    Isolated microparticles will be used to activate in vitro renal and pulmonary endothelial cells for the purpose of highlighting a possible cross talk, analyzing endothelial damage markers.


Other Outcome Measures:
  1. Levels of OPN in liquor and blood of patients with SAH [ Time Frame: Time course of OPN levels measured the day of bleeding and on days 1, 2, 3, 5, 7, 9, 11. ]
    Increase compared to the baseline i.e., day of the bleeding, of OPN level in liquor and blood of patients with SAH measured on days 1, 2, 3, 5, 7, 9, 11.


Biospecimen Retention:   Samples Without DNA
plasma, serum, urine, liquor


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with subarachnoid haemorrhage admitted to Neurosurgery or ICU of Ospedale Maggiore della Carita will be considered eligible, when meeting including criteria, within 24h from bleeding.
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years
  • Subarachnoid haemorrhage from cerebral aneurysm rupture
  • Indication to external liquor drainage

Exclusion Criteria:

  • Age less than 18 or more than 80 years
  • Bleeding occurred more than 24 hours before admission
  • Known coagulopathies or antiplatelet or vitamin K antagonist treatment

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): NCT03411746


Contacts
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Contact: Rosanna Vaschetto, Professor +393342724811 rosanna.vaschetto@med.uniupo.it

Locations
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Italy
Rosanna Vaschetto Recruiting
Novara, Italy, 28100
Contact: Rosanna Vaschetto, Professor    +393342724811    rosanna.vaschetto@med.uniupo.it   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
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Principal Investigator: Rosanna Vaschetto, Professor Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Publications:
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Responsible Party: Rosanna Vaschetto, MD, PhD, Prof., Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03411746     History of Changes
Other Study ID Numbers: CE 115/17
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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