Efficacy and Safety of Erythrocytapheresis in Chronic Mountain Sickness: the ESCAPE-CMS Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Incremental shuttle walk test
研究概览
简要总结
The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness
详细描述
This study aims to evaluate the efficacy and safety of erythrocytapheresis in patients with Chronic Mountain Sickness (CMS). Residents of high-altitude regions diagnosed with CMS will be enrolled and randomly allocated into two groups. The control group will receive standard of care, including supplemental oxygen and medical management. The intervention group will receive erythrocytapheresis in addition to standard of care. Clinical outcomes, including CMS scores, the Incremental Shuttle Walk Test (ISWT), and relevant hematological and hemodynamic indicators, will be assessed and compared between the two groups to determine the therapeutic benefit of erythrocytapheresis as a hematocrit-reduction strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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;
- •High-altitude residents or long-term dwellers (continuous residence at ≥2500 meters above sea level for at least 1 year), with no travel history to low-altitude areas in the past 3 months;
- •Hemoglobin (Hb): Men: ≥210 g/L, Women: ≥190 g/L; at least one symptom or sign: headache, dizziness, dyspnea, palpitations, sleep disturbances, fatigue, localized cyanosis, burning sensation in palms/soles, venous dilatation, muscle/joint pain, loss of appetite, poor concentration, or memory changes; CMS total score ≥6;
- •Written informed consent obtained from patients or their legal representatives.
排除标准
- •Hematocrit < 60%;
- •Patients with erythrocytosis attributable to: polycythemia vera; secondary erythrocytosis due to dehydration, cyanotic congenital heart disease, or chronic obstructive pulmonary disease; or other underlying hematologic or oncologic conditions;
- •Patients with active pneumonia, pulmonary embolism, or severe organ dysfunction (including cardiac, hepatic, or renal failure);
- •Patients with contraindications to study procedures (including erythrocytapheresis, pulmonary function tests, or incremental shuttle walk test), such as impaired consciousness, pneumothorax, severe arrhythmia, or significant coagulation disorders;
- •Patients who have received CMS-specific interventions within the last 6 months, including phlebotomy, erythrocytapheresis, or targeted pharmacotherapy;
- •Patients currently pregnant, breastfeeding, or planning to become pregnant within 1 year;
- •Any terminal condition with an estimated life expectancy of < 6 months;
- •Current participation in other clinical trials.
结局指标
主要结局
Incremental shuttle walk test
时间窗: Within 48 hours after treatment is completed
Measures the maximum distance a patient can walk at progressively increasing speeds until exhaustion, primarily assessing peak exercise capacity.
Chronic mountain sickness score
时间窗: Within 48 hours after treatment is completed and during follow-up period
A clinical tool used to assess the severity of chronic mountain sickness, also known as Monge's disease. It is based on symptoms and physiological markers related to excessive erythrocytosis (abnormally high red blood cell count) due to prolonged exposure to high altitude.
CMS symptom score
时间窗: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
CMS symptom score : The symptomatic severity of CMS is evaluated using the clinical component of the International Consensus Score. This sub-score excludes the hemoglobin concentration and focuses solely on the seven classic symptoms.
次要结局
- SF-6D v2 score(Within 48 hours after treatment is completed and during follow-up period)
- Blood oxygen saturation(Within 48 hours after treatment is completed and during follow-up period)
- Blood oxygen saturation(Within 48 hours after treatment is completed and during follow-up period)
- SF-6D v2 score(Within 48 hours after treatment is completed and during follow-up period)
- CMS total score(48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period)
- Incremental shuttle walk test(48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period)
- SF-6D score(48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period)
- Blood oxygen saturation(48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period)
- Procedure-related complications(48 - 72 hours post-erythrocytapheresis or prior to discharge for controls)
研究者
Ye Fan
Principal Investigator
Third Military Medical University