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Clinical Efficacy of Erythropheresis in High Altitude Polycythemia

Primary Purpose

High Altitude Polycythemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Erythropheresis
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Altitude Polycythemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NO.953 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Erythropheresis treatment

Routine treatment

Arm Description

Erythropheresis treatment was was added to routine treatment

Oxygen delivery and basic care

Outcomes

Primary Outcome Measures

6-Minute Walk Test
Measure walk distance during 6 minutes, to assess submaximal exercise capacity.
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.

Secondary Outcome Measures

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.
Prothrombin time
A test to measure how long it takes for your blood plasma to clot.
Oxygen saturation Oxygen saturation
The fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.

Full Information

First Posted
September 16, 2020
Last Updated
April 27, 2022
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04557995
Brief Title
Clinical Efficacy of Erythropheresis in High Altitude Polycythemia
Official Title
The Clinical Study on the Efficacy and Safety of Erythropheresis in High Altitude Polycythemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Polycythemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erythropheresis treatment
Arm Type
Experimental
Arm Description
Erythropheresis treatment was was added to routine treatment
Arm Title
Routine treatment
Arm Type
No Intervention
Arm Description
Oxygen delivery and basic care
Intervention Type
Procedure
Intervention Name(s)
Erythropheresis
Intervention Description
Draw blood from patient's vein and remove red blood cells as other components would be transfused back.
Primary Outcome Measure Information:
Title
6-Minute Walk Test
Description
Measure walk distance during 6 minutes, to assess submaximal exercise capacity.
Time Frame
Within 24 hours after treatment is completed
Title
Arterial partial pressure of oxygen
Description
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.
Time Frame
Within 24 hours after treatment is completed
Secondary Outcome Measure Information:
Title
Activated partial thromboplastin time
Description
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.
Time Frame
Within 24 hours after treatment is completed and during follow-up period
Title
Prothrombin time
Description
A test to measure how long it takes for your blood plasma to clot.
Time Frame
Within 24 hours after treatment is completed and during follow-up period
Title
Oxygen saturation Oxygen saturation
Description
The fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
Time Frame
Within 24 hours after treatment is completed and during follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jieru Guo
Phone
+8618883923067
Email
1193341071@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Fan
Organizational Affiliation
Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NO.953 Hospital
City
Shigatse
State/Province
Tibet
ZIP/Postal Code
857000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liang
Phone
18189028559
Email
906585334@qq.com

12. IPD Sharing Statement

Learn more about this trial

Clinical Efficacy of Erythropheresis in High Altitude Polycythemia

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