High-Altitude Polycythemia Study

ConditionsHigh-altitude Polycythemia HAPC

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorTibet Autonomous Region People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Disturbance of consciousness.

Inability to independently clear airway secretions, with the risk of aspiration.

Severe upper gastrointestinal bleeding.

Hemodynamic instability.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Intervention Group (NIV Treatment)Experimental treatment 1 intervention

Group B: Control Group (Standard Care Only)No intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Hemoglobin (Hb) Concentration

The primary endpoint is the absolute change in blood hemoglobin concentration (g/dL) from baseline to 3-month and 6-month follow-up. A reduction in hemoglobin level is defined as a clinically significant improvement in high altitude polycythemia status.

Time frame

Baseline, 3 months, 6 months after treatment initiation

Secondary outcomes

Change in Serum uric acid and blood lipid levels

Changes in serum uric acid, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured.

Time frame

Baseline, 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tibet Autonomous Region People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: