RecruitingNot Applicable

Erythrocytapheresis for Chronic Mountain Sickness

China112 participantsStarted 2025-07-21

Plain-language summary

The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

CMS symptom score

Timeframe: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period

NCT IDNCT04557995

SponsorThird Military Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Jieru Guo

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.