Erythrocytapheresis for Chronic Mountain Sickness
ConditionChronic Mountain Sickness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThird Military Medical University
About this trial
The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
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;
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;
Written informed consent obtained from patients or their legal representatives.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Erythropheresis
Procedure/SurgeryThe 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.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: ErythrocytapheresisExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
CMS symptom score
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.
Time frame
48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up periodSecondary outcomes
1
CMS total score
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.
Time frame
48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period2
Incremental shuttle walk test
Measures the maximum distance a patient can walk at progressively increasing speeds until exhaustion, primarily assessing peak exercise capacity.
Time frame
48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period3
SF-6D score
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.
Time frame
48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period4
Blood oxygen saturation
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.
Time frame
48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up periodSponsors and contacts
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Source ClinicalTrials.gov