Erythropheresis treatment for high altitude polycythemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study investigates the efficacy and safety of erythropheresis in patients diagnosed with high altitude polycythemia. Participants living in high-altitude regions are randomly assigned to receive either standard therapy, including oxygen therapy, or erythropheresis in addition to standard care. The study evaluates symptom relief, blood oxygenation levels, and performance on a 6-minute walk test to compare outcomes between the two groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• NO.953 Hospital
  Xigazê, Tibet, China Recruiting

Study contacts

• Principal investigator: Ye Fan — Third Military Medical University
• Study coordinator: Jieru Guo
• Email: 1193341071@qq.com
• Phone: +8618883923067

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.