Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-29 @ 5:54 PM
Study NCT ID:
NCT03706768
Status:
UNKNOWN
Last Update Posted:
2019-04-25
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 \[31\]
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: