The Effect of Strenuous Exercise on Coagulation.

Completed

• Conditions: The Effect of Strenuous Exercise on Haemostasis.

• Registration Number: NCT02048462
• Lead Sponsor: Synapse bv

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Study Start: 2014-04
• Primary Completion: 2014-04
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of strenuous exercise on thrombin generation and other coagulation tests.	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)

Trial Locations

Locations (1)

Synapse bv; 🇳🇱 Maastricht, Limburg, Netherlands