NCT04557995

Erythrocytapheresis for Chronic Mountain Sickness

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Mountain Sickness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-21
• Primary completion: 2029-01-01
• Completion: 2029-10-01
• First posted: 2020-09-22
• Last updated: 2026-04-02

Locations

1 site across 1 country: China