Chronic Mountain Sickness
Conditions
Brief summary
The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness
Detailed description
This study aims to evaluate the efficacy and safety of erythrocytapheresis in patients with Chronic Mountain Sickness (CMS). Residents of high-altitude regions diagnosed with CMS will be enrolled and randomly allocated into two groups. The control group will receive standard of care, including supplemental oxygen and medical management. The intervention group will receive erythrocytapheresis in addition to standard of care. Clinical outcomes, including CMS scores, the Incremental Shuttle Walk Test (ISWT), and relevant hematological and hemodynamic indicators, will be assessed and compared between the two groups to determine the therapeutic benefit of erythrocytapheresis as a hematocrit-reduction strategy.
Interventions
PROCEDUREErythropheresis
The procedure involves the extracorporeal removal of a specific volume of erythrocytes using an automated cell separator. Following the centrifugal separation of whole blood, the patient's plasma and other cellular components are concurrently re-infused, often supplemented with a replacement fluid (such as saline) to maintain isovolemia.
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMS symptom score | 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period | CMS symptom score : The symptomatic severity of CMS is evaluated using the clinical component of the International Consensus Score. This sub-score excludes the hemoglobin concentration and focuses solely on the seven classic symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood oxygen saturation | 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period | A measure of the percentage of hemoglobin binding sites in the bloodstream occupied by oxygen. It is a key indicator of respiratory and circulatory function, commonly assessed using a pulse oximeter. |
| Procedure-related complications | 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls | Procedure-related complications including venipuncture site reactions, systemic hypovolemic responses, anticoagulant-associated issues (such as bleeding or acute nephropathy), allergic reactions, or electrolyte imbalances |
| CMS total score | 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period | A clinical tool used to assess the severity of CMS. It is based on symptoms and HGB levels due to prolonged exposure to high altitude. |
| Incremental shuttle walk test | 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period | Measures the maximum distance a patient can walk at progressively increasing speeds until exhaustion, primarily assessing peak exercise capacity. |
| SF-6D score | 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period | A preference-based health utility measure derived from the SF-36 or SF-12 health surveys. It is widely used in health economics and clinical research to assess health-related quality of life and calculate Quality-Adjusted Life Years for cost-effectiveness analyses. |
Countries
China
Contacts
CONTACTJieru Guo
PRINCIPAL_INVESTIGATORYe Fan
Third Military Medical University
Outcome results
None listed