Erythrocytapheresis for Chronic Mountain Sickness
Efficacy and Safety of Erythrocytapheresis in Chronic Mountain Sickness: the ESCAPE-CMS Trial
Third Military Medical University
112 participants
Jul 21, 2025
INTERVENTIONAL
Conditions
Summary
The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria8
- 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.
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Interventions
The procedure involves the extracorporeal removal of a specific volume of erythrocytes using an automated cell separator. Following the centrifugal separation of whole blood, the patient's plasma and other cellular components are concurrently re-infused, often supplemented with a replacement fluid (such as saline) to maintain isovolemia.
Locations(1)
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NCT04557995