Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Syndecan-1 and heparin sulfate
研究概览
简要总结
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.
详细描述
- 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]
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age 18 years of age and older
- •Cerebral aneurysm on CT-angio
排除标准
- •• 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
研究组 & 干预措施
Glycocalyx
degree of glycocalyx breakdown in patients with aSAH
干预措施: Glycocalyx (Other)
结局指标
主要结局
Syndecan-1 and heparin sulfate
时间窗: 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.
次要结局
- serum Matrix metalloproteinase-1 and Matrix metalloproteinase-9(day 0 through day 13)
- urinary microalbumin-to-creatinine ratio (MACR)(day 0 through day13)
研究者
Danny Theodore, MD
Assistant Professor of Anesthesiology
University of Virginia