The objective is to investigate the effect of strenuous exercise (participation to the Amstel Gold Race) on coagulation and haemostatic parameters.
ID
Source
Brief title
Condition
- Haematological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Whole blood (WB) will be used for WB-TG, ROTEM, haematocrit, haemoglobin, and
platelet count testing. Plasma will be stored for plasma-TG, PT, APTT, dRVVT-X,
measurement of the factor concentrations (II, V, VII, VIII, IX, X, XI, XII,
fibrinogen, protein C/S), ADAMTS-13, VWF (antigen/activity), D-dimers and a
fibrinolysis assay. Additionally, we will also look at the heart frequency,
blood pressure and oxygen levels, cardiac biomarkers and a questionnaire on the
trainingsstatus of the participants.
Secondary outcome
Not applicable.
Background summary
Many studies have shown that vigorous exercise increases the risk of developing
vascular thrombotic events and can result in sudden death during or immediately
after exercise. The outcome of these studies is biased by several confounding
variables: subjects, type of exercise, duration, intensity and especially the
method used for the evaluation of the hemostatic capacity. The goal of our
study is to investigate the effect of strenuous exercise with the Calibrated
Automated Thrombogram (CAT) assay, which is an established tool in detecting
hyper- and hypocoagulabilty conditions. We modified the CAT assay to make it
also feasible to measure TG in whole blood (WB-CAT), not only to go one step
closer to physiology since all the blood cells are present, but also to avoid
the centrifugation step.
With our study we would like to see whether the other blood cells also play a
role in the increase in TG.
Study objective
The objective is to investigate the effect of strenuous exercise (participation
to the Amstel Gold Race) on coagulation and haemostatic parameters.
Study design
Healthy participants of the Amstel Gold Race for non-professionals will be
asked to join our study. Blood samples will be taken via venipuncture (23 ml)
and fingerprick (15 µl) before and after the Race.
Study burden and risks
23ml of blood will be taken twice from each subject, one sample will be taken
before the Amstel Gold Race and one sample will be taken after the Race. Blood
sampling will be done by experienced medical researchers and will only cause
short bruising. There is no direct benefit for the patients and the patients do
not have to come back for the purpose of our study.
Oxfordlaan 70
Maastricht 6229EV
NL
Oxfordlaan 70
Maastricht 6229EV
NL
Listed location countries
Age
Inclusion criteria
• Healthy subjects not taking any medication interfering with coagulation that are willing to donate 23 ml of blood via venipuncture and a capillary blood drop via fingerpuncture before and after the Amstel Gold Race.
• 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, *).
• 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 below 18 years or above 50 years of age.
• Subjects that smoke.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02048462 |
| CCMO | NL47367.068.13 |