PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis (PROTECT-ASUC)
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ClinicalTrials.gov Identifier: NCT04411784 |
Recruitment Status :
Active, not recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
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Sponsor:
Hull University Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust
Tracking Information | |||||
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First Submitted Date | May 29, 2020 | ||||
First Posted Date | June 2, 2020 | ||||
Last Update Posted Date | June 2, 2020 | ||||
Actual Study Start Date | May 20, 2020 | ||||
Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Primary outcome measure: The need for in-hospital colectomy or rescue therapy [ Time Frame: 3 months ] The need for in-hospital colectomy or rescue therapy
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis | ||||
Official Title | PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis: A Multi-centre Observational Case- Control Study | ||||
Brief Summary | Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes | ||||
Detailed Description | The study aims to evaluate the process, evaluation and therapy variation in management of ASUC with reference to 2019 British Society of Gastroenterology guidelines and see whether there are any differences between ambulatory and hospital management in ASUC. Also to evaluate the outcomes in ASUC patients managed during the COVID-19 pandemic | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | In The UK alone approximately 6500 patients are admitted with ASUC each year | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Sebastian S, Walker GJ, Kennedy NA, Conley TE, Patel KV, Subramanian S, Kent AJ, Segal JP, Brookes MJ, Bhala N, Gonzalez HA, Hicks LC, Mehta SJ, Lamb CA; PROTECT-ASUC Study Group. Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study. Lancet Gastroenterol Hepatol. 2021 Feb 2. pii: S2468-1253(21)00016-9. doi: 10.1016/S2468-1253(21)00016-9. [Epub ahead of print] | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Estimated Enrollment |
200 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 2020 | ||||
Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years to 100 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04411784 | ||||
Other Study ID Numbers | 284030 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Hull University Teaching Hospitals NHS Trust | ||||
Study Sponsor | Hull University Teaching Hospitals NHS Trust | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Hull University Teaching Hospitals NHS Trust | ||||
Verification Date | May 2020 |