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Recruiting
NCT04557995
Erythrocytapheresis for Chronic Mountain Sickness
Conditions: Chronic Mountain Sickness
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 112
Sponsor: Third Military Medical University
Location: NO.953 Hospital Xigazê Tibet
Summary
The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness
Eligibility Criteria
Inclusion:
1. Age ≥18 years;
2. 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;
3. 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;
4. Written informed consent obtained from patients or their legal representatives.
Exclusion:
1. Hematocrit \< 60%;
2. 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;
3. Patients with active pneumonia, pulmonary embolism, or severe organ dysfunction (including cardiac, hepatic, or renal failure);
4. 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;
5. Patients who have received CMS-specific interventions within the last 6 months, including phlebotomy, erythrocytapheresis, or targeted pharmacotherapy;
6. Patients currently pregnant, breastfeeding, or planning to become pregnant within 1 year;
7. Any terminal condition with an estimated life expectancy of \< 6 months;
8. Current participation in other clinical trials.
Source: ClinicalTrials.gov (NCT04557995). StuddyBuddy aggregates publicly available trial information.