Clinical Efficacy of Erythropheresis in High Altitude Polycythemia
Study Details
Study Description
Brief Summary
The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Erythropheresis treatment Erythropheresis treatment was was added to routine treatment |
Procedure: Erythropheresis
Draw blood from patient's vein and remove red blood cells as other components would be transfused back.
|
No Intervention: Routine treatment Oxygen delivery and basic care |
Outcome Measures
Primary Outcome Measures
- 6-Minute Walk Test [Within 24 hours after treatment is completed]
Measure walk distance during 6 minutes, to assess submaximal exercise capacity.
- 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.
Secondary Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
=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:
- 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | NO.953 Hospital | Shigatse | Tibet | China | 857000 |
Sponsors and Collaborators
- Third Military Medical University
Investigators
- Principal Investigator: Ye Fan, Third Military Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HAP_2020