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

Completed

Conditions: bloodcoagulation / disturbed coagulation
10064477

Registration Number: NL-OMON38743

Lead Sponsor: niversiteit Maastricht

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures