Clinical Efficacy of Erythropheresis in High Altitude Polycythemia

Sponsor
Third Military Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04557995
Collaborator
(none)
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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
  • Procedure: Erythropheresis
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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Clinical Study on the Efficacy and Safety of Erythropheresis in High Altitude Polycythemia
Actual Study Start Date :
Sep 21, 2020
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

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

  1. 6-Minute Walk Test [Within 24 hours after treatment is completed]

    Measure walk distance during 6 minutes, to assess submaximal exercise capacity.

  2. 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

  1. 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.

  2. 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.

  3. 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

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Ye Fan, Principal Investigator, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT04557995
Other Study ID Numbers:
  • HAP_2020
First Posted:
Sep 22, 2020
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022