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Completed

NCT Number: NCT02048462

The Effect of Strenuous Exercise on Coagulation.

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Synapse bv

Maastricht, Limburg, 6229EV, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The effect of strenuous exercise on thrombin generation and other coagulation tests.

    Time frame: Before and after the Amstel Gold Race (around 6 hours)

    Thrombin generation will be done in whole blood and plasma. The parameters we will study at are: the peak height, ETP, lagtime, time-to-peak and velocity index.

    Routine coagulation tests (APTT, PT, INR, platelet count, haematocrit, fibrinolysis assay, FACS, ROTEM, ABO-determination, dRVVT-X, D-dimers) Measurements of coagulations factor levels (II, V, VII, VIII, IX, X, XI, XII, fibrinogen, protein S and C, ADAMTS-13)

Sponsors and collaborators

Lead sponsor

Synapse bv

Industry

Collaborators

  • Maastricht University

Registry information

Official study title

The Effect of Strenuous Exercise on Coagulation: Hemostatic Behaviour Before and After Amstel Gold Race

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2014
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.