Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2021-05-01
2023-11-30
Brief Summary
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Contact activation system measures are compared in a cross sectional (healthy controls vs. active disease) and longitudinal (active diasese vs. inactive disease) fashion.
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Detailed Description
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Registered data are:
* Demographics realate to UC and general wellbeing.
* Clinical parametres used for UC evaluation are PRO2, SCCAI, CRP, fecal calprotectin, Mayo endoscopic subscore and Nancy index.
* The contact activation system is characterised by FXII, prekallikrein, kallikrein generation, HK, cHK (specific to plasma kallikrein), cHK (specific to tissue kallikrein), C1 inhibitor and Kallistatin.
* Polymerized alpha-1-antitrypsin is characterised by the degree of polymerization and the capacity to activate the contact activation system.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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UC group
Patients with active ulcerative colitis
Continuously assessment of disease activity
Continuous measures of disease activity and activity in the contact activation system.
Interventions
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Continuously assessment of disease activity
Continuous measures of disease activity and activity in the contact activation system.
Eligibility Criteria
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Inclusion Criteria
* SCCAI score ≥ 5
* Mayo Endoscopic Subscore ≥ 1
* Age ≥ 18 years
* Most understand written and oral information in Danish
* Informed consent must be given
Exclusion Criteria
* Infection at inclusion
* Any existing disease at inclusion:
* liver disease or defect in CAS
* inflammatory rheumatologic or dermatologic disease
* cardiovascular or renal disease
* immunodeficiency or hematologic diseases
* malignancies
* Medication with
* Systemic corticosteroids at inclusion
* ACE-inhibitor
* Acetylsalicylic acid/NSAID
* Warfarin, Phenprocoumon, NOAC and heparins
18 Years
ALL
Yes
Sponsors
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UMC Utrecht
OTHER
University of Southern Denmark
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Responsible Party
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Morten Lee Halling
Principal Investigator
Principal Investigators
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Morten L Halling, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Medical Gastroenterology, University Hospital of Southern Denmark - Esbjerg
Locations
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Department of Medical Gastroenterology, University Hospital of Southern Denmark
Esbjerg, , Denmark
Countries
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Other Identifiers
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CAS UC
Identifier Type: -
Identifier Source: org_study_id
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