Acute Pancreatitis and Coagulation Study (APK)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Diagnostic test: Exploratory for different markers

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• Sweden
  • Skåne County
    • Malmö, Skåne County, Sweden, 20502
      • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted with Acute Pancreatitis at Skåne University Hospital in Malmö

Description

Inclusion Criteria: Acute Pancreatitis, accept informed consent -

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

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild acute pancreatitis; Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients	Diagnostic test: Exploratory for different markers; Test biomarkers for development of mild, moderate or severe disease
moderately severe acute pancreatitis; Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients	Diagnostic test: Exploratory for different markers; Test biomarkers for development of mild, moderate or severe disease
severe acute pancreatitis; Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients	Diagnostic test: Exploratory for different markers; Test biomarkers for development of mild, moderate or severe disease

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Sara Regnér, MD, PhD, Region Skåne and Lund University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: biomarkers; Acute Pancreatitis; severity prediction
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 2016/490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publications. Upon request from other researchers or publishers with scientific interest and in accordance with GDPR regulations
• IPD Sharing Time Frame: During 2023
• IPD Sharing Access Criteria: Upon request from other researchers or publishers with scientific interest and in accordance with GDPR regulations
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No