Erythrocytapheresis for Chronic Mountain Sickness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-21

Study Completion Date

2029-10-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Mountain Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Erythrocytapheresis

Erythrocytapheresis was was added to routine treatment

Group Type EXPERIMENTAL

Erythropheresis

Intervention Type PROCEDURE

Draw blood from patient's vein and remove red blood cells as other components would be transfused back.

Routine treatment

Oxygen delivery and basic care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erythropheresis

Draw blood from patient's vein and remove red blood cells as other components would be transfused back.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No