Acute Pancreatitis and Coagulation Study

Acute Pancreatitis Clinical Trial

— APK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201053
• Other study ID #: 2016/490
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 1, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Acute Pancreatitis, accept informed consent -

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

-

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Diagnostic Test:
• Exploratory for different markers
Test biomarkers for development of mild, moderate or severe disease

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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