Acute Pancreatitis and Coagulation Study

NCT05201053 | Completed

• 1 other identifier: 2016/490
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Acute Pancreatitis; biomarkers; severity prediction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Moderately Severe Acute Pancreatitis

  14 days

Study Arms (3)

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

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

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

Interventions

Exploratory for different markers DIAGNOSTIC_TEST

Test biomarkers for development of mild, moderate or severe disease

Mild acute pancreatitis; moderately severe acute pancreatitis; severe acute pancreatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Lund University: collaborator
• Region Skane: lead

Study Sites (1)

Skåne University Hospital

Malmö, Skåne County, 20502, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma. For some patients alveolar fluid.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Sara Regnér, MD, PhD

  Region Skåne and Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 21, 2022
• Study Start: May 1, 2017
• Primary Completion: May 31, 2022
• Study Completion: June 1, 2023
• Last Updated: May 1, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: During 2023
• Access Criteria: Upon request from other researchers or publishers with scientific interest and in accordance with GDPR regulations

Locations

SE (1)