None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male participants aged 18 to 60 years 2. Healthy individuals with no known pre-existing medical conditions as determined by study screening 3. Individuals scheduled to stay at high altitude for a minimum duration of 07 days 4. Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Inability or unwillingness to provide informed consent 2. History of pre-existing vascular thrombosis 3. Known hemoglobinopathies (e.g., sickle cell disease, thalassemia) 4. Pre-existing hypertension diagnosed prior to induction into high altitude 5. Pre-existing diabetes mellitus diagnosed prior to induction into high altitude 6. Dyslipidemia requiring medical management 7. Pre-existing renal disease (including chronic kidney disease or significant renal impairment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of vascular thrombosis (including venous and arterial thrombotic events) in participants during high altitude exposure, confirmed by clinical,laboratory and radiological evaluationTimepoint: Predefined time points: At baseline T1 taken at sea level prior to induction to High Altitude (HA); T2 taken at 6 days post induction to HA. T3 and T4 taken at 90 and 180 days post induction respectively. T5 sample is taken at time of de-induction from HA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in hematological and coagulation biomarkers during high altitude exposureTimepoint: At predefined time points T1 to T5 during follow up;Association between baseline biomarker levels and subsequent development of vascular thrombosisTimepoint: Baseline assessment and follow up up to 24 months;Comparison of biomarker profiles between participants who develop thrombosis and those who do notTimepoint: At time of event and corresponding matched time points in controls;Temporal changes in biomarker levels in response to high altitude exposureTimepoint: Serial measurements from baseline through all follow up visits (T1 to T5) | — |
Countries
India
Contacts
Public ContactDr Sanjeevan Sharma
153 General Hospital Leh
Outcome results
None listed