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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
112
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.
NO.953 Hospital
Xigazê, Tibet, China
RECRUITINGCMS 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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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