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

University of Virginia

Status: Unknown

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Other: Glycocalyx

Study type: Interventional

Funder types: Other

Identifiers

NCT03706768

170016

Details and patient eligibility

About

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.

Full 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]

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Glycocalyx

Other group

Description:

degree of glycocalyx breakdown in patients with aSAH

Treatment:

Other: Glycocalyx