Chronic Mountain SicknessNCT04557995
Erythrocytapheresis for Chronic Mountain Sickness
A study testing Erythropheresis in people with Chronic Mountain Sickness, run by Third Military Medical University at 1 site in China.
Trial summary
The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Mountain Sickness
- What is being tested?
- Erythropheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2025to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
NO.953 Hospital
Xigazê, Tibet, 857000
Jun Liang, 18189028559, 906585334@qq.com
About this study
Official title: 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
Read the 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
- Being tested
- Erythropheresis
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropheresisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Erythrocytapheresis | Experimental | Erythrocytapheresis plus standard of care Receives: Procedure: Erythropheresis |
| Standard of care | No intervention | Oxygen delivery and basic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start21 Jul 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Fan, Third Military Medical University
- Investigators
- Ye Fan, Principal investigator, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557995
- Sponsor's protocol ID
- ESCAPE-CMS
- Status last verified
- Mar 2026
- First submitted
- 16 Sep 2020
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Shou XY, Xiang Q, Liang J, Wu N, Yang R, Wu YM, Zhang J, Li YD, Jiao YD, Chen DY, He XL, Yang J, Fan Y. Efficacy and safety of erythrocytapheresis in chronic mountain sickness: a randomised controlled trial protocol (ESCAPE-CMS). BMJ Open. 2026 Oct 5;16(10):e121061. doi: 10.1136/bmjopen-2026-121061.
PubMed 42833714
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Erythrocytapheresis in Chronic Mountain Sickness: the ESCAPE-CMS Trial
- ClinicalTrials.gov ID
- NCT04557995
- Acronym / sponsor ID
- ESCAPE-CMS
- Conditions
- Chronic Mountain Sickness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythrocytapheresis | Experimental | Procedure: ErythropheresisErythrocytapheresis plus standard of care |
| Standard of care | No intervention | –Oxygen delivery and basic care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythropheresisThe 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. | Procedure or surgery | Erythrocytapheresis |
Primary outcome
CMS symptom score
Time frame: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
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.
5 secondary outcomes
CMS total score
Time frame: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
Incremental shuttle walk test
Time frame: 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
SF-6D score
Time frame: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
Blood oxygen saturation
Time frame: 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period
Procedure-related complications
Time frame: 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 42833714Shou XY, Xiang Q, Liang J, Wu N, Yang R, Wu YM, Zhang J, Li YD, Jiao YD, Chen DY, He XL, Yang J, Fan Y. Efficacy and safety of erythrocytapheresis in chronic mountain sickness: a randomised controlled trial protocol (ESCAPE-CMS). BMJ Open. 2026 Oct 5;16(10):e121061. doi: 10.1136/bmjopen-2026-121061.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ye Fan principal investigator
Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythropheresis in people with Chronic Mountain Sickness, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jieru Guo (+8618883923067, 1193341071@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMS symptom score (time frame: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.