Efficacy and safety of erythrocytapheresis in chronic mountain sickness: a randomised controlled trial protocol (ESCAPE-CMS)
5 affiliations
- 1Department of Respiratory Disease, Army Medical University Xinqiao Hospital, Chongqing, China
- 2Shigatse Branch, Xinqiao Hospital, Third Military Medical University, Shigatse, China
- 3Department of Epidemiology, Army Medical University College of Preventive Medicine, Chongqing, China
- 4Department of High Mountain Sickness, General Hospital of Tibet Military Command, Lhasa, China
- 5Department of Internal Medicine, PLA 956th Hospital, Linzhi, China
Abstract
Introduction: Chronic mountain sickness (CMS) is a clinical syndrome affecting more than 4 million individuals living at high altitudes, primarily characterised by excessive polycythaemia. Current CMS consensus recommends therapies targeting haematocrit (HCT), such as phlebotomy or isovolemic haemodilution. However, the clinical benefit of HCT-reduction strategies in CMS has yet to be established. This trial aims to evaluate whether erythrocytapheresis, regarded as one of the most precise and effective approaches for HCT-reduction, could improve clinical outcomes in patients with CMS.
Methods and analysis: Efficacy and safety of erythrocytapheresis in chronic mountain sickness is an investigator-initiated, multicentre, randomised controlled superiority trial with blinded outcome assessment. A total of 112 eligible CMS patients will be consecutively randomised to receive either standard care alone or standard care plus erythrocytapheresis with a 1:1 ratio. The primary efficacy endpoint is the net change in CMS symptom score assessed at 48 hours post-erythrocytapheresis or prior to discharge for controls. The primary safety outcome is treatment-related adverse events before discharge. The primary outcome will be analysed using an analysis of covariance, with a clinical threshold for superiority.
Ethics and dissemination: Ethics approval was obtained from the Medical Ethics Committees of the coordinating centre (Xinqiao Hospital, 2020–014-02) and each participating centre. Written informed consent will be acquired prior to enrolment. The trial results will be submitted for publication in a peer-reviewed journal.
Trial registration number: NCT04557995 .
Related
- Sex-specific efficacy of acetazolamide for acute mountain sickness. A randomised clinical trial.
- Efficacy and tolerability of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomised, controlled, double-blind phase 1/2 trial
- Efficacy and safety of oxfendazole in adults with Trichuris spp. infection in Pemba Island, Tanzania: a double-blind, phase 2a, randomised controlled trial
- Ketone monoester intake attenuates exercise performance decline in normobaric hypoxia: A post‐hoc subgroup analysis of 5 young male adults without acute mountain sickness
- Integrative Multi-Omics and Network Pharmacology Analyses Reveal Potential Mechanisms of Codonopsis pilosula in Mountain Sickness
BibTeX
@article{shou2026efficacy,
title = {{Efficacy and safety of erythrocytapheresis in chronic mountain sickness: a randomised controlled trial protocol (ESCAPE-CMS)}},
author = {Xin-Yi Shou and Qing Xiang and Jun Liang and Na Wu and Rui Yang and Yan-Min Wu and Jing Zhang and Yi-Ding Li and Yu-Ding Jiao and Dong-Yang Chen and Xiao-Long He and Jun Yang and Ye Fan},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-121061},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121061},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Efficacy and safety of erythrocytapheresis in chronic mountain sickness: a randomised controlled trial protocol (ESCAPE-CMS)
AU - Xin-Yi Shou
AU - Qing Xiang
AU - Jun Liang
AU - Na Wu
AU - Rui Yang
AU - Yan-Min Wu
AU - Jing Zhang
AU - Yi-Ding Li
AU - Yu-Ding Jiao
AU - Dong-Yang Chen
AU - Xiao-Long He
AU - Jun Yang
AU - Ye Fan
PY - 2026
DA - 2026/10/05
JO - BMJ Open
DO - 10.1136/bmjopen-2026-121061
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121061
AB - Introduction: Chronic mountain sickness (CMS) is a clinical syndrome affecting more than 4 million individuals living at high altitudes, primarily characterised by excessive polycythaemia. Current CMS consensus recommends therapies targeting haematocrit (HCT), such as phlebotomy or isovolemic haemodilution. However, the clinical benefit of HCT-reduction strategies in CMS has yet to be established. This trial aims to evaluate whether erythrocytapheresis, regarded as one of the most precise and effective approaches for HCT-reduction, could improve clinical outcomes in patients with CMS. Methods and analysis: Efficacy and safety of erythrocytapheresis in chronic mountain sickness is an investigator-initiated, multicentre, randomised controlled superiority trial with blinded outcome assessment. A total of 112 eligible CMS patients will be consecutively randomised to receive either standard care alone or standard care plus erythrocytapheresis with a 1:1 ratio. The primary efficacy endpoint is the net change in CMS symptom score assessed at 48 hours post-erythrocytapheresis or prior to discharge for controls. The primary safety outcome is treatment-related adverse events before discharge. The primary outcome will be analysed using an analysis of covariance, with a clinical threshold for superiority. Ethics and dissemination: Ethics approval was obtained from the Medical Ethics Committees of the coordinating centre (Xinqiao Hospital, 2020–014-02) and each participating centre. Written informed consent will be acquired prior to enrolment. The trial results will be submitted for publication in a peer-reviewed journal. Trial registration number: NCT04557995 .
SN - 2044-6055
SN - 2044-6055
ER -