Skip to content

Mont Blanc: where red meets white: The effect of altitude on thrombin generation

Mont Blanc: where red meets white: The effect of altitude on thrombin generation - The Mont Blanc study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38743
Enrollment
30
Registered
2013-04-17
Start date
2013-06-04
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

bloodcoagulation / disturbed coagulation

Interventions

Due to the climbing there will be reduced oxygen in the air, so the volunteers will experience hypoxia.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Healthy subjects (not having any morbidity and without obvious sign of illness and not taking any medication interfering with coagulation) living in the Netherlands and willing to travel to the Mont Blanc area for 11 days and to donate 18ml blood 5 times during this trip. • All healthy volunteers will undergo a physical check-up in April by an authorized medical doctor. During this physical check-up the doctor will look at the ECG before and after exercise (cycling), the blood pressure, the heart rate and blood oxygen level. • Between 18 and 50 years of age. We take 50 year as a maximal age to prevent any co-morbidity that could have an influence on coagulation (like diabetes, atherosclerosis, peripheral arterial disease, *). • Although only walking through snow will be done, requirement for joining this study: any mountain experience on the level of C1 (see website NKBV), • Etnicity will not be included as an inclusion or exclusion criteria.

Exclusion criteria

Exclusion criteria: • Subjects taking any medication interfering with coagulation. • Subjects having a cardiovascular disease or any other serious medical problem. • Subjects with a mobility impairment (not being able of walking by themselves or on a normal manner without discomfort for the subject). • Subjects below 18 years of age. • Subject that did not pass the physical check-up.

Design outcomes

Primary

MeasureTime frame
• TG in whole blood (peak height, ETP, lagtime, time-to-peak, velocity index) • TG in plasma (peak height, ETP, lagtime, time-to-peak, velocity index) • Rotem (MCF, CFT, CT, alpha-angle, ML with intem, extem, fibtem and aptem) • Routine coagulation tests (APTT, PT, INR, platelet count, haematocrit, fibrinolysis assay, dRVVT-X) • Measurements of coagulations factor levels (II, V, VII, VIII, IX, X, XI, XII, protein S and C, ADAMTS-13)

Secondary

MeasureTime frame
• Blood pressure, heart frequency, body temperature, electrocardiogram, blood oxygen level.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)