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van CCT (UK)

Invloed van inspanning door middel van wielrennen op het haemostatisch profiel.

- candidate number14348
- NTR NumberNTR3846
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-feb-2013
- Secondary IDsNL42855.068.12 CCMO
- Public TitleInvloed van inspanning door middel van wielrennen op het haemostatisch profiel.
- Scientific TitleEffect of cycling exercise on the haemostatic profile.
- hypothesisDoes cycling exercise induce increased coagulation activity through contact activation?
- Healt Condition(s) or Problem(s) studiedCoagulation, Physical exercise, Platelet aggregation, Cycling, Thrombin generation
- Inclusion criteria1. Minimal 18 years old;
2. Trains more than 3 times a week;
3. Mentally competent.
- Exclusion criteria1. Diagnosed with coagulation or platelet disorder;
2. Using medication against coagulation or platelet function;
3. Vascular operation within 6 months before the research;
4. BMI > 30;
5. Prestation influencing drugs;
6. Pregnancy.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2013
- planned closingdate1-jun-2013
- Target number of participants40
- InterventionsBlood will be collected before and after long-term strenuous exercise. Coagulation profile will be measured bij Thrombin Generation (CAT), Rotem;Natem and by measuring Thrombin-Antithrombin complex , Coagulation Factor XIa (FXIa), tissue Plasminogen Activator (tPA), D-Dimer and von Willebrand Factor (vWf). Platelet reactivity will be assesed by Multiplate. Blood cell counts are determined for testing the full blood cell count profile by: Hematocrit, Haemoglobin, platelets, cortisol and leukocytes (differentiation).
- Primary outcomeExpecting to show increased coagulation activity by increased TAT levels, supported by decreased Coagulation Time (CT) and enhanced Maximal clotting formation (MCF) by Rotem and enhanced thrombin generation through CAT assay. Increased fibrinolytic activity is expected by increased tPA and D-Dimer levels. Coagulation activation via the intrinsic pathway can be showed by enhanced thrombin generation in Active Side Inhibitor factor Seven (ASIS) assay. Increased platelet reactivity is expected by multiplate accompanied by a increase in platelet count. Moreover we expect increase vWf levels, due to endothelial dysfunction.
- Secondary outcomeSecondary outcomes can be a change in Hematocrit and Haemoglobin, due to plasma volume changes.

Moreover, outcomes can be that cycling exercise induces a internal haemostatic profile that can contribute to pathofysiological disease which are very common in cycling, endofibrose of the iliacal artery. Characterized by subendothelial fibrotic tissue formation. Protease Activated Receptors are known that they can induce fibrotic tissue formation and can be activated by coagulation factors (FXa and Thrombin).
- TimepointsMarch 2013: Start of study.
Every 2 weeks a group of 5 cyclists and controle groupe will be tested. So 20 cyclists and 20 controle group members will be tested within 2 months.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Laboratory for Clinical Thrombosis and Haemostasis, Department of Internal Medicine, 
Cardiovascular Research Institute Maastricht, Maastricht University Medical Center
- PublicationsN/A
- Brief summaryAlthough a clear association between exercise and activation of coagulation has been demonstrated, evidence is fragmented and the trigger remains unknown. Given the protease activated receptor (PAR) activation by coagulation proteases and the subsequent cellular effects such as inflammation, migration and apoptosis, haemostatic changes during exercise may contribute to the development of endofibrosis in cyclists. This pathology is characterized by intimal thickening of the iliacal artery, with reduced blood flow as a consequence.
- Main changes (audit trail)
- RECORD8-feb-2013 - 16-feb-2013

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