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Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT03706768
Recruitment Status : Unknown
Verified April 2019 by Danny Theodore, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : October 16, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Danny Theodore, MD, University of Virginia

Study Description
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Brief Summary:
This study will provide novel information to the literature base for the pathophysiology of aneurysmal subarachnoid hemorrhage. The association of breakdown products in the serum of aSAH patients were reported in a very small case series of 3 patients, as mentioned above. However, while their results are intriguing and encouraging, our study will provide more definitive information about the GC in aSAH. If there is a positive correlation, the results of this study will guide future investigations into new therapies for this devastating disease such as MMP inhibition with doxycycline.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Other: Glycocalyx Not Applicable

Detailed Description:

  1. The study will aim to recruit all eligible patients at UTMCK and the University of Virginia hospital over a 12 month period. Our main outcome measure is degradation of the glycocalyx in patients with aSAH. All eligible patients with confirmed aSAH admitted to the neuro-intensive care unit will be enrolled after consent is obtained from the family and/or the patient. Serum samples will be drawn from each patient on admission (day 1) and every other day until day 13 for a total of 7 samples per patient.

    The following serum tests will be performed:

  2. Measurement of serum syndecan-1 by ELISA
  3. Measurement of serum heparan-sulfate by ELISA
  4. Measurement of serum matrix metalloproteinases -9
  5. Measurement of serum matrix-metalloproteinase-1
  6. Measurement of urinary microalbumin-to-creatinine ratio
  7. Measurement of daily TCDs (all patients currently receive daily TCDs as part of the aSAH protocol at UTMCK and UVA Hospital)

  8. Outcomes:

    a) Chart review: i) Incidence of DCI as defined by a consensus committee on this subject and published in the journal Stroke [29].

    ii) In-hospital mortality will be recorded b) Follow-up performed by phone call or searching the Social Security Death Index [30]: i) 30-day mortality ii) 90-day mortality c) Outcomes follow-up: i) The Glasgow Outcome Scale 12 weeks post aSAH [31]

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Aneurysmal Subarachnoid Hemorrhage
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Glycocalyx
degree of glycocalyx breakdown in patients with aSAH
 Other: Glycocalyx
Measure Degradation of the Glycocalyx


Outcome Measures
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Primary Outcome Measures :
  1. Syndecan-1 and heparin sulfate [ Time Frame: day 0 through day 13 ]
    Compare the degree of glycocalyx breakdown in patients with aSAH who develop delayed cerebral ischemia (DCI) to those that do not develop DCI. This will be completed by measuring the breakdown of Syndecan-1 and heparin sulfate in the blood.


Secondary Outcome Measures :
  1. serum Matrix metalloproteinase-1 and Matrix metalloproteinase-9 [ Time Frame: day 0 through day 13 ]
    serum MMP-9 and MMP-1 will be levels will be measured as serum MMP concentrations have been positively correlated with the incidence of delayed cerebral ishemia

  2. urinary microalbumin-to-creatinine ratio (MACR) [ Time Frame: day 0 through day13 ]
    urinary microalbumin-to-creatinine ratio (MACR) will be measured as it is marker of systemic damage to the glycocalyx


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Age 18 years of age and older

    • Cerebral aneurysm on CT-angio

Exclusion Criteria:

  • • comfort care only orders,

    • the absence of an aneurysm on CT-angiography,
    • onset of aneurysm rupture > 24 hours,
    • and inability to obtain informed consent from patient or family pregnant women
Contacts and Locations
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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): NCT03706768


Contacts
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Contact: Marcia E Birk 434-924-2283 meb2w@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Marcia E Birk         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Daniel Theodore, MD University of Virginia
More Information
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Publications:

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Responsible Party: Danny Theodore, MD, Assistant Professor of Anesthesiology, University of Virginia
ClinicalTrials.gov Identifier: NCT03706768    
Other Study ID Numbers: 170016
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Subarachnoid Hemorrhage
Brain Ischemia
Cerebral Infarction
Hemorrhage
Ischemia
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke
Infarction
Necrosis