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High-Altitude Polycythemia Study

No phase Interventional High-altitude Polycythemia HAPC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-invasive ventilator.
Who it may be relevant to
Registry conditions: High-altitude Polycythemia, HAPC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Study on the Therapeutic Effect of Non-Invasive Ventilator in the Treatment of High-Altitude Polycythemia

Overview

This study aims to evaluate the clinical efficacy of non-invasive ventilation (NIV) in treating patients with high-altitude polycythemia (HAPC). Participants will be enrolled according to the international diagnostic criteria for high-altitude polycythemia. The study will use both retrospective cohort and prospective study methods. All participants will receive standard basic care. In addition, the intervention group will receive non-invasive ventilation treatment using either BiPAP or CPAP mode. Key measurements, including routine blood tests, liver function, renal function, uric acid, blood lipid profile, electrocardiogram and echocardiography, will be collected as primary and secondary outcome measures to assess the effects of the treatment.

Interventions

  • Other Non-invasive ventilator
    Treatment with non-invasive ventilator (CPAP, BiPAP) in the intervention group.

Primary outcome measures

  • Change in Hemoglobin (Hb) Concentration [Time frame: Baseline, 3 months, 6 months after treatment initiation]
Secondary outcome measures (1)
  • Change in Serum uric acid and blood lipid levels [Time frame: Baseline, 6 months]

Eligibility criteria

Inclusion criteria

  • Diagnosed with high-altitude polycythemia (HAPC).
  • Aged 18 years or older, with no gender restriction.
  • Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

  • Disturbance of consciousness.
  • Inability to independently clear airway secretions, with the risk of aspiration.
  • Severe upper gastrointestinal bleeding.
  • Hemodynamic instability.
  • Upper airway obstruction.
  • Un drained pneumothorax or mediastinal emphysema.
  • Conditions that prevent mask wearing, such as facial trauma or deformity.
  • Patient non-compliance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • People's Hospital of Xizang Autonomous Region；Lhasa, Xizang Autonomous Region, China, 8500 — Xizang
  • Xizang Autonomous Region People's Hospital — Xizang

Identifiers

NCT: NCT07600086 · ME-TBHP-25-014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗