Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage (SAH): a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
The goal of this observational study is to understand if angiographic cerebral vasospasm (CV) can be predicted by levels of nitric oxide (NO) consumption in patients with aneurysmal subarachnoid hemorrhage (SAH). To reach this goal, the investigators will compare NO consumption levels in SAH and non-SAH patients. NO consumption levels will be analyzed from samples of participants' cerebral spinal fluid (CSF).
详细描述
After enrollment, the investigators will collect patients' demographics and most relevant clinical characteristics of the patients.
For patients with SAH, the investigators will collect an-1 ml aliquot of CSF from the drainage circuit daily, (using a sterile procedure that involves a valve of the closed system circuit located distally to the patient, before the collection container), for a period of 15 days following SAH. The samples will be stored at -80 degrees.
The investigators will perform daily Transcranial Doppler (TCD) monitoring to assess whether the patients have cerebral vasospasm. In case of suspected vasospasm, and in all comatose patients after 4 days from the bleeding, a CT angiography will be performed to define the angiographic CV.
For the control group, discarded 1 ml-aliquot of CSF will be collected at the time of needle insertion for spinal anesthesia.
At the end of the protocol, the study population will be divided in 3 groups:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient with SAH and with an external ventricular drainage (EVD) placed within 24 hours after the onset of the hemorrhage
排除标准
- •pregnancy
- •pre-existing neurological comorbidities
- •coagulation disorders
- •absence of a good cranial window to perform Transcranial Doppler (TDC)
- •presence of >50% stenosis of carotid arteries confirmed by doppler ultrasound
- •Technical problems on EVD that prevent CSF withdrawals
- •For the control group, we will invite to participate patients without neurological comorbidities undergoing spinal anesthesia in the operating room or with a spinal drain for major vascular surgery.
研究者
Lorenzo Berra, MD
Lorenzo Berra, MD, Assistant Professor, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School
Massachusetts General Hospital