Erythrocytapheresis for Chronic Mountain Sickness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erythropheresis.
- Who it may be relevant to
- Registry conditions: Chronic Mountain Sickness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Erythrocytapheresis in Chronic Mountain Sickness: the ESCAPE-CMS Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- CMS symptom score [Time frame: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion:
- 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.
Exclusion:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- NO.953 Hospital — Xigazê
Identifiers
NCT: NCT04557995 · ESCAPE-CMS