Exhaled Carbon Monoxide as a Marker of Hemolysis in Sickle Cell Disease- an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Exhaled Carbon Monoxide Level and hemolysis markers
研究概览
简要总结
The investigators propose to evaluate etCO in patients with HbSS, HbSC, and HbS-beta thalassemia during routine clinic visits, and longitudinally. Our goal is to know whether etCO differs amongst subjects with different sickle cell syndrome genotypes, and whether it is a stable marker of hemolytic rate, as reflected in routine labs obtained for clinical care (including total hemoglobin, reticulocyte count, lactate dehydrogenase, and, when sampled, total and direct bilirubin). We hope to establish whether this inexpensive and non-invasive test faithfully reflects hemolytic parameters in sickle cell syndromes.
详细描述
This is an observational study of sickle cell patients with the aim to measure exhaled carbon monoxide levels and to correlate with genotype and standard clinical markers of hemolysis.
Upon enrollment and at each subsequent visit, if acceptable to the patient, each subject will undergo measurement of exhaled carbon monoxide utilizing a hand held carbon monoxide monitor, MicroCO/Smoke check. Subsequent evaluations may be obtained during a routine visit, while hospitalized for a vasocclusive crises (VOC) episode, or when evaluated in the acute care clinic.
The principal study objective is to assess if exhaled carbon monoxide levels are a non-invasive marker of hemolysis in subjects with sickle cell disease (SCD).
The secondary study objective is to assess exhaled carbon monoxide levels serially in subjects with SCD, relative to vasocclusive crises, transfusion requirements, and pain syndromes.
The one inclusion criteria is for all adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •All adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions.
排除标准
- •A recent (2 week) history of lung infection, asthma, acute chest syndrome, or COPD exacerbation and/or a significant pulmonary dysfunction in the recent (3-6 month) past.
结局指标
主要结局
Exhaled Carbon Monoxide Level and hemolysis markers
时间窗: Participants will be followed for the duration of two years, at baseline clinically, or while hospitalized for a VOC episode, or when evaluated in the acute care clinic for pain or symptom exacerbation.
Exhaled Carbon Monoxide Levels will be measured serially, at clinical baseline and with symptom exacerbation.
次要结局
未报告次要终点
研究者
Jane Little
Professor
University Hospitals Cleveland Medical Center