Acute Pancreatitis and Coagulation Study

NCT ID: NCT05201053

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Acute Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild acute pancreatitis

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

Exploratory for different markers

Intervention Type DIAGNOSTIC_TEST

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

Exploratory for different markers

Intervention Type DIAGNOSTIC_TEST

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

Exploratory for different markers

Intervention Type DIAGNOSTIC_TEST

Test biomarkers for development of mild, moderate or severe disease

Interventions

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Exploratory for different markers

Test biomarkers for development of mild, moderate or severe disease

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Regnér, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne and Lund University

Locations

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Skåne University Hospital

Malmo, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2016/490

Identifier Type: -

Identifier Source: org_study_id

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