Erythropheresis treatment for high altitude polycythemia

Efficacy and Safety of Erythrocytapheresis in Chronic Mountain Sickness: the ESCAPE-CMS Trial

This study tests if a blood treatment called erythropheresis can help people with high altitude polycythemia feel better and breathe easier compared to standard therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 1 site (Xigazê, Tibet)
• Trial ID: NCT04557995 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Han nationality adults aged 18 and older who have lived in high-altitude areas for over 12 months and have been diagnosed with high altitude polycythemia.

Not a fit: Patients with hypoxemia due to other respiratory or cardiac diseases, or those with acute mountain sickness, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from high altitude polycythemia.

How similar studies have performed: While erythropheresis has been used in other contexts, this specific application for high altitude polycythemia is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Xigazê, Tibet

• NO.953 Hospital — Xigazê, Tibet, China (Recruiting)

Study contacts

• Principal investigator: Ye Fan — Third Military Medical University
• Study coordinator: Jieru Guo

Conditions Chronic Mountain Sickness