Acute Pancreatitis and Coagulation Study

Study Overview
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Brief Summary
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The study aims to investigate pathophysiological changes in coagulation in relation to inflammation in patients with acute pancreatitis. Serum and plasma is sampled repeated days from admission. Analysis will be done after recruitment. Specific biomarkers accuracy for prediction of moderate and severer acute pancreatitis will be calculated.

Detailed Description
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Inclusion criteria: Patients with acute pancreatitis admitted to Skåne University Hospital in Malmö Acute pancreatitis is defined as minimum 2 out of following: amylase levels >3 times upper reference limit, clinical signs of acute pancreatitis, imaging findings of acute pancreatitis) Exclusion criteria: <18 years of age >72 hours from onset of symtom until first sampling Patients with immunosuppression or autoimmune diseases are excluded from som parts of the study. Methods: Serum and plasma is sampled repeatedly during the hospital admission. Pre defined protocols are used for data collections of relevant clinical information. Specific aspects of inflammation, thrombin generation, platelet function and Microparticles will be analysed in serum or plasma during the first consecutive days of acute pancreatitis. Biomarkers for severe disease as well as correlation between inflammation and coagulopathy will be investigated.

Official Title
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Coagulation Disturbances and Thrombosis in Acute Pancreatitis (Koagulopati Och Trombos Vid Akut Pankreatit-APK Studien)

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Diagnostic Test: Exploratory for different markers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Pancreatitis, accept informed consent - Exclusion Criteria: More than 72h from onset of symtoms until first sample, patient already included once -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild acute pancreatitis<br>Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients | Diagnostic Test: Exploratory for different markers<br>* Test biomarkers for development of mild, moderat or severe disease<br>|
| moderately severe acute pancreatitis<br>Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients | Diagnostic Test: Exploratory for different markers<br>* Test biomarkers for development of mild, moderat or severe disease<br>|
| severe acute pancreatitis<br>Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients | Diagnostic Test: Exploratory for different markers<br>* Test biomarkers for development of mild, moderat or severe disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe acute pancreatitis | According to Revised Atlanta which is a consensus document where organ failure (defined by modified Marshall score) less than 48hours or signs of local complications on CT scan defines severity. This is not a scale but a generally used definition according to the paper: Banks PA, et al. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013;62(1):102-11. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderately Severe Acute Pancreatitis | According to Revised Atlanta which is a consensus document where organ failure (defined by modified Marshall score) less than 48hours or signs of local complications on CT scan defines severity. This is not a scale but a generally used definition according to the paper: Banks PA, et al. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013;62(1):102-11. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pancreatitis, coagulation, inflammation, biomarkers, severity prediction