Erythrocytapheresis for Chronic Mountain Sickness

Efficacy and Safety of Erythrocytapheresis in Chronic Mountain Sickness: the ESCAPE-CMS Trial

The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness

Study Overview

• Status: Recruiting
• Conditions: Chronic Mountain Sickness
• Intervention / Treatment: Procedure: Erythropheresis

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jieru Guo; Phone Number: +8618883923067; Email: 1193341071@qq.com

Study Locations

• China
  • Tibet
    • Xigazê, Tibet, China, 857000
      • Recruiting
      • NO.953 Hospital
      • Contact: Jun Liang; Phone Number: 18189028559; Email: 906585334@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erythrocytapheresis; Erythrocytapheresis plus standard of care	Procedure: Erythropheresis; 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.
No Intervention: Standard of care; Oxygen delivery and basic care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
Incremental shuttle walk test	Measures the maximum distance a patient can walk at progressively increasing speeds until exhaustion, primarily assessing peak exercise capacity.	48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
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.	48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
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.	48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
Procedure-related complications	Procedure-related complications including venipuncture site reactions, systemic hypovolemic responses, anticoagulant-associated issues (such as bleeding or acute nephropathy), allergic reactions, or electrolyte imbalances	48 - 72 hours post-erythrocytapheresis or prior to discharge for controls

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Principal Investigator: Ye Fan, Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: ESCAPE-CMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No