- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Agroup of IBD patients in activity
|
Effect of IBD disease and activity of disease on coagulation parameters
|
|
Normal controlled group
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of IBD patients in activity with DVT
기간: Within one year dollow up
|
Within one year dollow up
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .