Acute Pancreatitis and Coagulation Study

Completed

• Conditions: Acute Pancreatitis
• Interventions: Diagnostic Test: Exploratory for different markers

• Registration Number: NCT05201053
• Lead Sponsor: Region Skane

Brief Summary

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

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-21
• Primary Completion: 2022-05-31
• Study Completion: 2023-06-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

Acute Pancreatitis, accept informed consent -

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild acute pancreatitis	Exploratory for different markers	Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients
moderately severe acute pancreatitis	Exploratory for different markers	Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients
severe acute pancreatitis	Exploratory for different markers	Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients

Primary Outcome Measures

Name	Time	Method
Severe acute pancreatitis	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 Outcome Measures

Name	Time	Method
Moderately Severe Acute Pancreatitis	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.

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Malmö, Skåne, Sweden