|- candidate number||19357|
|- NTR Number||NTR4806|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-aug-2014|
|- Secondary IDs||METC143032 |
|- Public Title||The Mont Blanc study 2|
|- Scientific Title||The Mont Blanc study 2: where red and white meet again|
|- hypothesis||We hypothesize that the interaction between blood cells, platelets, red blood cells or monocytes and the plasma compartment is responsible for the increase in thrombotic risk. Therefore, we aim to investigate the effect of hypoxia on the blood cells, how/why they get activated, develop microparticles, and express anionic phospholipids on their outer membrane. In order to achieve this we also need to establish whether the results of a stay in the hypoxic chamber are comparable to a stay at high altitude, regardless of the difference in barometric pressure. We do not expect differences in physical activity or gender during the stay in a hypoxic chamber, but we need to exclude this. Last but not least, we would like to investigate whether reoxygenation also plays a role in the development of thrombosis after hypoxia.|
|- Healt Condition(s) or Problem(s) studied||Thrombosis, Hypoxia|
|- 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||• 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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2014|
|- planned closingdate||1-nov-2015|
|- Target number of participants||28|
|- Interventions||Induction of hypoxia by either going on altitude or by a stay in a low oxygen chamber.|
|- Primary outcome||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 outcome||• 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.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Ninivaggi|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Ninivaggi|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM), Synapse b.v.|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||27-aug-2014 - 18-okt-2014|