- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04115722
Coagulation Parameters in IBD Patients
- to assess the incidence of coagulation disorders in IBD patients in comparison with another normal controlled group
- risk factors that contribute to development of thrombosis in IBD patients
- to determine the effectiveness of prophlactive anticoagulant measures
- to determine the association between disease activity and coagulation parameters
Panoramica dello studio
Descrizione dettagliata
Inflammatory bowel disease is a group of disorders associated with chronic, recurrent, and immune system-mediated inflammation of The bowel mucosa . The reported global incidence and prevalence rates for ulcerative colitis vary between 1.2-20.3 and 6-246 per 100000 persons, respectively, and the corresponding figures for Crohns disease are 0.03-15.6 and 3.6-214 [2 In a population based cohort study involving 1160 patients with ulcerative colitis, the complication-related mortality rate was 9.6% during follow-up period of 35 years, in another study, 221 patients with Crohns disease were followed up for 33 years, with an overall complication-related mortality rate of Of the extra-intestinal manifestations of inflammatory bowel disease (IBD), thromboembolic events represent a major cause of morbidity and mortality with a 3.6 times increased risk in comparison with the general population .
Although clinical observations suggest an incidence rate between 1 and 8% for thromboembolic events in subjects with IBD, postmortem studies point out to a much higher occurrence rate around 41% . As a matter of fact, these and similar findings have led to an increased interest in the search for the association between IBD and hypercoagulable states as a potential cause of increased morbidity and mortality due to thromboembolic events in IBD . For instance, the existence of documentable prothrombotic abnormalities and a positive history for thromboembolic complications were demonstrated in at least one third of the subjects with IBD in a study by Solem et al Inflammation and coagulation are two crucial systems that are in balance and constantly influence each other. The impact of inflammation on coagulation has been confirmed by several experimental studies showing that inflammatory mechanism shift the hemostatic balance to favor the activation of coagulation which, in turn, can also sustain inflammation promoting a vicious circle between chronic inflammation and thrombosis
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
All patients of IBD more than 18 years
Exclusion Criteria:
-All IBD patients less than 18 years-all diseases that cause coagulation disorders all diseases that cause coagulation disorders ( liver diseases , collagen diseases, other auto immune disease
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Agroup of IBD patients in activity
|
Effect of IBD disease and activity of disease on coagulation parameters
|
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Normal controlled group
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Percentage of IBD patients in activity with DVT
Lasso di tempo: Within one year dollow up
|
Within one year dollow up
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May;126(6):1504-17. doi: 10.1053/j.gastro.2004.01.063.
- Dolapcioglu C, Soylu A, Kendir T, Ince AT, Dolapcioglu H, Purisa S, Bolukbas C, Sokmen HM, Dalay R, Ovunc O. Coagulation parameters in inflammatory bowel disease. Int J Clin Exp Med. 2014 May 15;7(5):1442-8. eCollection 2014.
- Sartor RB. Mechanisms of disease: pathogenesis of Crohn's disease and ulcerative colitis. Nat Clin Pract Gastroenterol Hepatol. 2006 Jul;3(7):390-407. doi: 10.1038/ncpgasthep0528.
- Winther KV, Jess T, Langholz E, Munkholm P, Binder V. Survival and cause-specific mortality in ulcerative colitis: follow-up of a population-based cohort in Copenhagen County. Gastroenterology. 2003 Dec;125(6):1576-82. doi: 10.1053/j.gastro.2003.09.036.
- Truelove SC, Pena AS. Course and prognosis of Crohn's disease. Gut. 1976 Mar;17(3):192-201. doi: 10.1136/gut.17.3.192.
- Talbot RW, Heppell J, Dozois RR, Beart RW Jr. Vascular complications of inflammatory bowel disease. Mayo Clin Proc. 1986 Feb;61(2):140-5. doi: 10.1016/s0025-6196(12)65200-8.
- Miehsler W, Reinisch W, Valic E, Osterode W, Tillinger W, Feichtenschlager T, Grisar J, Machold K, Scholz S, Vogelsang H, Novacek G. Is inflammatory bowel disease an independent and disease specific risk factor for thromboembolism? Gut. 2004 Apr;53(4):542-8. doi: 10.1136/gut.2003.025411.
- Jackson LM, O'Gorman PJ, O'Connell J, Cronin CC, Cotter KP, Shanahan F. Thrombosis in inflammatory bowel disease: clinical setting, procoagulant profile and factor V Leiden. QJM. 1997 Mar;90(3):183-8. doi: 10.1093/qjmed/90.3.183.
- Irving PM, Pasi KJ, Rampton DS. Thrombosis and inflammatory bowel disease. Clin Gastroenterol Hepatol. 2005 Jul;3(7):617-28. doi: 10.1016/s1542-3565(05)00154-0.
- Solem CA, Loftus EV, Tremaine WJ, Sandborn WJ. Venous thromboembolism in inflammatory bowel disease. Am J Gastroenterol. 2004 Jan;99(1):97-101. doi: 10.1046/j.1572-0241.2003.04026.x.
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Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Coagulation parameters in IBD
Informazioni su farmaci e dispositivi, documenti di studio
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