Clinical Efficacy of Erythropheresis in High Altitude Polycythemia

High Altitude Polycythemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557995
• Other study ID #: HAP_2020
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: October 1, 2026

Study information

• Verified date: November 2023
• Source: Third Military Medical University
• Contact: Jieru Guo
• Phone: +8618883923067
• Email: 1193341071[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Polycythemia
• Polycythemia

Intervention

Procedure:
• Erythropheresis
Draw blood from patient's vein and remove red blood cells as other components would be transfused back.

Locations

Country	Name	City	State
China	NO.953 Hospital	Shigatse	Tibet

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Minute Walk Test	Measure walk distance during 6 minutes, to assess submaximal exercise capacity.	Within 24 hours after treatment is completed
Primary	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	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
Secondary	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
Secondary	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