Other Clinical Trial - Degradation of the Glycocalyx in Delayed Cerebral

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03706768
Study type	Interventional
Source	University of Virginia
Contact	Marcia E Birk
Phone	434-924-2283
Email	meb2w@virginia.edu
Status	Recruiting
Phase	N/A
Start date	May 1, 2018
Completion date	May 1, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms