Erythrocytapheresis for Chronic Mountain Sickness

NCT04557995 | Recruiting

• 1 other identifier: ESCAPE-CMS
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Mountain Sickness

Outcome Measures

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.

  48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period

Secondary Outcomes (5)

• CMS total score

  48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period

• Incremental shuttle walk test

  48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period

• SF-6D score

  48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period

• Blood oxygen saturation

  48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period

• Procedure-related complications

  48 - 72 hours post-erythrocytapheresis or prior to discharge for controls

Study Arms (2)

Erythrocytapheresis

EXPERIMENTAL

Erythrocytapheresis plus standard of care

Procedure: Erythropheresis

Standard of care

NO INTERVENTION

Oxygen delivery and basic care

Interventions

Erythropheresis PROCEDURE

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.

Erythrocytapheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hematocrit \< 60%;
• 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;
• Patients with active pneumonia, pulmonary embolism, or severe organ dysfunction (including cardiac, hepatic, or renal failure);
• 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;
• Patients who have received CMS-specific interventions within the last 6 months, including phlebotomy, erythrocytapheresis, or targeted pharmacotherapy;
• Patients currently pregnant, breastfeeding, or planning to become pregnant within 1 year;
• Any terminal condition with an estimated life expectancy of \< 6 months;
• Current participation in other clinical trials.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

NO.953 Hospital

Xigazê, Tibet, 857000, China

RECRUITING

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ye Fan

  Third Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieru Guo

CONTACT

+8618883923067; 1193341071@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: July 21, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)