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RecruitingNCT04557995Updated Aug 25, 2026

Erythrocytapheresis for Chronic Mountain Sickness

An interventional study of Erythropheresis in Chronic Mountain Sickness, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Chronic Mountain Sickness

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03

In context

Altitude Sickness

216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.

This study's planned enrollment of 112 is above the median of 34 across 178 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  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. (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 obtained from patients or their legal representatives.

Exclusion criteria

Exclusion:

  1. Hematocrit \< 60%;
  2. Patients with erythrocytosis attributable to: polycythemia vera; secondary erythrocytosis due to dehydration, cyanotic congenital heart disease, or ; 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 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 of \< 6 months;
  8. Current participation in other clinical trials.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    Erythrocytapheresis

    Erythrocytapheresis plus standard of care

    Procedure: Erythropheresis

  • No intervention
    Standard of care

    Oxygen delivery and basic care

Interventions

  • ProcedureErythropheresis

    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.

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What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. Incremental shuttle walk test

    Measures the maximum distance a patient can walk at progressively increasing speeds until exhaustion, primarily assessing peak exercise capacity.

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

  3. 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.

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

  4. 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.

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

  5. 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

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

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes

Access criteria: De-identified data will be made available upon reasonable request to the corresponding author, subject to a data sharing agreement and ethics approval where required.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jan 2029, 41 months after the start.

Of 76 non-industry interventional studies with no phase under Altitude Sickness, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 41 months is above that.

Counting every sponsor, half of 76 studies reached it within 9 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2020
First posted
Sep 22, 2020
StartActual
Jul 21, 2025
Primary completionEst.
Jan 1, 2029
CompletionEst.
Oct 1, 2029
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04557995
Lead sponsor
Third Military Medical University
Responsible party
Ye Fan (Principal Investigator, Third Military Medical University) — Principal investigator
First posted
Sep 22, 2020
Start date
Jul 21, 2025
Primary completion
Jan 1, 2029 (estimated)
Completion
Oct 1, 2029 (estimated)
Last update
Aug 25, 2026

Study contacts

Jieru Guo
Contact
1193341071@qq.com
+8618883923067
Ye Fan
principal investigator · Third Military Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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