Clinical Efficacy of Erythropheresis in High Altitude Polycythemia

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

Detailed Description
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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.

Official Title
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The Clinical Study on the Efficacy and Safety of Erythropheresis in High Altitude Polycythemia

Conditions
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High Altitude Polycythemia

Intervention / Treatment
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* Procedure: Erythropheresis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropheresis treatment<br>Erythropheresis treatment was was added to routine treatment | Procedure: Erythropheresis<br>* Draw blood from patient's vein and remove red blood cells as other components would be transfused back.<br>|
| No Intervention: Routine treatment<br>Oxygen delivery and basic care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Walk Test | Measure walk distance during 6 minutes, to assess submaximal exercise capacity. | Within 24 hours after treatment is completed | 
| Arterial partial pressure of oxygen | 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. | Within 24 hours after treatment is completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activated partial thromboplastin time | 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. | Within 24 hours after treatment is completed and during follow-up period | 
| Prothrombin time | A test to measure how long it takes for your blood plasma to clot. | Within 24 hours after treatment is completed and during follow-up period | 
| Oxygen saturation Oxygen saturation | The fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood. | Within 24 hours after treatment is completed and during follow-up period |