Acute Pancreatitis and Coagulation Study (APK)

Region Skane

Status: Completed

Conditions: Acute Pancreatitis

Treatments: Diagnostic Test: Exploratory for different markers

Study type: Observational

Funder types: Other

Identifiers

NCT05201053

2016/490

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Acute Pancreatitis, accept informed consent -

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

Trial design

141 participants in 3 patient groups

Mild acute pancreatitis

Description:

Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients

Treatment:

Diagnostic Test: Exploratory for different markers

moderately severe acute pancreatitis

Description:

Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients

Treatment:

Diagnostic Test: Exploratory for different markers

severe acute pancreatitis

Description:

Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients

Treatment:

Diagnostic Test: Exploratory for different markers