Erythrocytapheresis for Chronic Mountain Sickness

Not Applicable

Recruiting

• Conditions: Chronic Mountain Sickness

• Registration Number: NCT04557995
• Lead Sponsor: Third Military Medical University

Brief Summary

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

Detailed 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. 6-minute walk test, symptom relief, and CMS score et al would be assessed and compared in the above two groups.

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Status Verified: 2025-07
• Study Start: 2025-07-21
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-25
• Primary Completion: 2029-01-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6-Minute Walk Test	Within 48 hours after treatment is completed	Measure walk distance during 6 minutes, to assess submaximal exercise capacity.

Secondary Outcome Measures

Name	Time	Method
Chronic mountain sickness score	Within 48 hours after treatment is completed and during follow-up period	A clinical tool used to assess the severity of chronic mountain sickness, also known as Monge's disease. It is based on symptoms and physiological markers related to excessive erythrocytosis (abnormally high red blood cell count) due to prolonged exposure to high altitude.
SF-6D v2 score	Within 48 hours after treatment is completed 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 (HRQoL) and calculate Quality-Adjusted Life Years (QALYs) for cost-effectiveness analyses.
Blood oxygen saturation	Within 48 hours after treatment is completed 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 (a non-invasive device that clips onto a finger, earlobe, or toe).

Trial Locations

Locations (1)

NO.953 Hospital; 🇨🇳 Shigatse, Tibet, China