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The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythrocytapheresis | Experimental | Erythrocytapheresis plus standard of care |
|
| Standard of care | No Intervention | Oxygen delivery and basic care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropheresis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period |
| Incremental shuttle walk test |
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Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieru Guo | Contact | +8618883923067 | 1193341071@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Fan | Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NO.953 Hospital | Recruiting | XigazĂȘ | Tibet | 857000 | China |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
Measures the maximum distance a patient can walk at progressively increasing speeds until exhaustion, primarily assessing peak exercise capacity. |
| 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. | 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. | 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 | 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls |