Clinical Efficacy of Erythropheresis in High Altitude Polycythemia

Not Applicable

Recruiting

• Conditions: High Altitude Polycythemia
• Interventions: Procedure: Erythropheresis

• Registration Number: NCT04557995
• Lead Sponsor: Third Military Medical University

Brief Summary

The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia.

Detailed Description

The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia. People reside in highland diagnosed as high-altitude polycythemia were included and randomly divided into two groups. In one group, routine therapy including oxygen inspiration would be performed, while in another erythropheresis would be added. Symptom relief, blood oxygenation, and 6-minute walk test would be assessed and compared in the above two groups.

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study Start: 2020-09-21
• Study First Posted: 2020-09-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-01-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. >=18 years old;2.High altitude polycythemia; 3.Han nationality who have been in highland for over 12 months; 4. No other complications indicated by general examinations such as chest X-ray, electrocardiogram; 5. patients who are informed and informed consent form are acquired.

Exclusion Criteria

1. Hypoxemia caused by other respiratory or cardiac diseases or polycythemia vera; 2. Acute or subacute mountain sickness ; 3. Acute or chronic infections and medication history ; 4. Psychiatric disorders or severe neurosis; 5. Malignant myeloproliferative disease; 6. Any contraindications to erythropheresis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythropheresis treatment	Erythropheresis	Erythropheresis treatment was was added to routine treatment

Primary Outcome Measures

Name	Time	Method
Arterial partial pressure of oxygen	Within 24 hours after treatment is completed	The partial pressure of oxygen, is a measurement of oxygen pressure in arterial blood. It reflects how well oxygen is able to move from the lungs to the blood.
6-Minute Walk Test	Within 24 hours after treatment is completed	Measure walk distance during 6 minutes, to assess submaximal exercise capacity.

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation Oxygen saturation	Within 24 hours after treatment is completed and during follow-up period	The fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
Activated partial thromboplastin time	Within 24 hours after treatment is completed and during follow-up period	A screening test to evaluate the overall integrity of the intrinsic/common coagulation pathway. This test reflects the activities of most of the coagulation factors in the intrinsic and common procoagulant pathway, but not the extrinsic procoagulant pathway, which includes factor VII and tissue factor, nor the activity of factor XIII.
Prothrombin time	Within 24 hours after treatment is completed and during follow-up period	A test to measure how long it takes for your blood plasma to clot.

Trial Locations

Locations (1)

NO.953 Hospital; 🇨🇳 Shigatse, Tibet, China