Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706768
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Danny Theodore, MD, University of Virginia

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]

Layout table for study information
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

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location contacts
Contact: Marcia E Birk 434-924-2283 meb2w@virginia.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Daniel Theodore, MD University of Virginia
Publications:

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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