Erythrocytapheresis for Chronic Mountain Sickness

Third Military Medical University

Status: Enrolling

Conditions: Chronic Mountain Sickness

Treatments: Procedure: Erythropheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT04557995

HAP_2020

Details and patient eligibility

About

The clinical study is aimed to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness

Full description

The clinical study is aimed to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness. People reside in highland diagnosed as chronic mountain sickness were included and randomly divided into two groups. In one group, routine therapy including oxygen inspiration would be performed, while in another erythropheresis would be added. Incremental shuttle walk test, symptom relief, and CMS score et al would be assessed and compared in the above two groups.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

1. High-altitude residents or long-term dwellers (defined as continuous residence at ≥2,500 meters above sea level for ≥1 year), with no history of travel to low-altitude areas in the preceding 2 months and no planned travel to low-altitude areas during the study period;
2. Aged more than 18 years, any gender;
3. Diagnosed with CMS per the Qinghai CMS Criteria: Hemoglobin (Hb): Men: ≥210 g/L Women: ≥190 g/L At least one symptom/sign: headache, dizziness, dyspnea and/or 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 score ≥6;
4. Women of childbearing potential: negative pregnancy test (serum/urine) at screening. No pregnancy plans during the study period;
5. Willing to sign informed consent and able to comply with study procedures.

Exclusion:

1. Hematocrit <60%;
2. Patients with polycythemia due to: polycythemia vera, underlying cardiopulmonary diseases (e.g. COPD, chronic bronchitis, bronchiectasis, pulmonary fibrosis, heart disease), or other causes including malignancy;
3. Patients with active pneumonia, acute/chronic pulmonary embolism, or severe organ dysfunction (including cardiac, hepatic, or renal failure);
4. patients with contraindications to study procedures: erythrocytapheresis, pulmonary function tests, incremental shuttle walk test et al, including conditions such as pneumothorax, impaired consciousness, severe arrhythmia, or significant coagulation disorders et al.;
5. recent CMS-specific treatments (within the past 6 months): drug therapy, phlebotomy, or erythrocytapheresis;
6. pregnant or breastfeeding women;
7. current participation in other clinical trial (observational studies permitted).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Erythrocytapheresis

Experimental group

Description:

Erythrocytapheresis was was added to routine treatment

Treatment:

Procedure: Erythropheresis

Routine treatment

No Intervention group

Description:

Oxygen delivery and basic care