Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Interventions
- Other: Glycocalyx
- Registration Number
- NCT03706768
- Lead Sponsor
- 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.
- 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 \[31\]
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
-
• Age 18 years of age and older
- Cerebral aneurysm on CT-angio
-
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glycocalyx Glycocalyx degree of glycocalyx breakdown in patients with aSAH
- Primary Outcome Measures
Name Time Method Syndecan-1 and heparin sulfate 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
Name Time Method serum Matrix metalloproteinase-1 and Matrix metalloproteinase-9 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
urinary microalbumin-to-creatinine ratio (MACR) day 0 through day13 urinary microalbumin-to-creatinine ratio (MACR) will be measured as it is marker of systemic damage to the glycocalyx
Trial Locations
- Locations (1)
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States