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Completed

NCT Number: NCT05201053

Acute Pancreatitis and Coagulation Study

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne University Hospital

Malmö, Skåne County, 20502, Sweden

About this study

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 symptom 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Acute Pancreatitis, accept informed consent -

Exclusion criteria

More than 72h from onset of symptoms until first sample, patient already included once

-

Treatment and study plan

Exploratory for different markers

Diagnostic Test

Test biomarkers for development of mild, moderate or severe disease

Primary outcomes

  1. Severe acute pancreatitis

    Time frame: 14 days

    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.

Secondary outcomes

  1. Moderately Severe Acute Pancreatitis

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Acronym: APK

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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