Erythrocytapheresis for Chronic Mountain Sickness

Официальное название

Efficacy and Safety of Erythrocytapheresis in Chronic Mountain Sickness: the ESCAPE-CMS Trial

Обзор

The study aims to explore the efficacy and safety of erythrocytapheresis in chronic mountain sickness

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• CMS symptom score [Срок оценки: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period]

Вторичные конечные точки (5)

• CMS total score [Срок оценки: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period]
• Incremental shuttle walk test [Срок оценки: 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period]
• SF-6D score [Срок оценки: 48 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period]
• Blood oxygen saturation [Срок оценки: 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls, and during follow-up period]
• Procedure-related complications [Срок оценки: 48 - 72 hours post-erythrocytapheresis or prior to discharge for controls]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• NO.953 Hospital — Xigazê

Идентификаторы

NCT: NCT04557995 · ESCAPE-CMS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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