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The Mont Blanc study 2

The Mont Blanc study 2: where red and white meet again

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23647
Enrollment
28
Registered
2014-08-27
Start date
2014-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypoxia altitude thrombosis thrombin generation

Interventions

Induction of hypoxia by either going on altitude or by a stay in a low oxygen chamber.

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Healthy subjects (not having any morbidity and without obvious sign of illness and not taking any medication interfering with coagulation) willing to participate to both parts of our study. • All healthy volunteers will undergo a physical check-up by an authorized medical doctor. During this physical check-up the doctor will look at the ECG, the blood pressure, the heart rate and blood oxygen level. • Between 18 and 50 years of age. We take 50 years as a maximal age to prevent any co-morbidity that could have an influence on coagulation (like diabetes, atherosclerosis, peripheral arterial disease, …).

Exclusion criteria

Exclusion criteria: • Subjects taking any medication interfering with coagulation. • Subjects having a cardiovascular disease or any other serious medical problem. • Subjects below 18 or above 50 years of age.

Design outcomes

Primary

MeasureTime frame
Thrombin generation will be done in whole blood and plasma with and without the addition of exogenous thrombomodulin. The parameters we will study at are: the peak height, ETP, lagtime, time-to-peak and velocity index. Samples after TG will be fixated for scanning electron microscopy (SEM) for cell morphology. Facs experiments will be performed for PS-exposure and platelet reactivity. Flow experiments for thrombus formation analysis with microfluidic chips.

Secondary

MeasureTime frame
• Routine coagulation tests (APTT, PT, INR, platelet count, haematocrit) • Measurements of coagulations factor levels (II, V, VII, VIII, IX, X, protein S and C, hemoglobin) • Blood pressure, heart frequency, blood oxygen level.

Contacts

Public ContactM. Ninivaggi
M.Ninivaggi@thrombin.com+31/43/3885890

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)