Clinical Trials Directory

Trials / Unknown

UnknownNCT03706768

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
42 (estimated)
Sponsor
University of Virginia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 \[31\]

Conditions

Interventions

TypeNameDescription
OTHERGlycocalyxMeasure Degradation of the Glycocalyx

Timeline

Start date
2018-05-01
Primary completion
2020-05-01
Completion
2020-05-01
First posted
2018-10-16
Last updated
2019-04-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03706768. Inclusion in this directory is not an endorsement.