Clinical trial NCT02048462: The Effect of Strenuous Exercise on Coagulation.
Official title: The Effect of Strenuous Exercise on Coagulation: Hemostatic Behaviour Before and After Amstel Gold Race
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Effect of Strenuous Exercise on Haemostasis.
Lead sponsor: Synapse bv
Sponsor class: INDUSTRY
Collaborators: name: Maastricht University
First posted: 2014-01-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants of the Amstel Gold Race for non-professionals will be asked to join our study.

Brief 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. The objective is to investigate the effect of strenuous exercise (participation to the Amstel Gold Race) on coagulation and haemostatic parameters. We hypothesize that strenuous exercise induces a prothrombotic phenotype and that especially the tests involving blood cells will be altered into a prothrombotic phenotype.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects not taking any medication interfering with coagulation that are willing to donate 18 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, ...).

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.

Primary outcomes:
measure: The effect of strenuous exercise on thrombin generation and other coagulation tests.
timeFrame: Before and after the Amstel Gold Race (around 6 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Synapse bv
state: Limburg
Study officials:
References:
citation: Huskens D, Roest M, Remijn JA, Konings J, Kremers RM, Bloemen S, Schurgers E, Selmeczi A, Kelchtermans H, van Meel R, Meex SJ, Kleinegris MC, de Groot PG, Urbanus RT, Ninivaggi M, de Laat B. Strenuous exercise induces a hyperreactive rebalanced haemostatic state that is more pronounced in men. Thromb Haemost. 2016 Jun 2;115(6):1109-19. doi: 10.1160/TH15-10-0821. Epub 2016 Feb 11.