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Acute Pancreatitis and Coagulation Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05201053
Acronym
APK
Enrollment
141
Registered
2022-01-21
Start date
2017-05-01
Completion date
2023-06-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Keywords

Acute Pancreatitis, biomarkers, severity prediction

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.

Interventions

DIAGNOSTIC_TESTExploratory for different markers

Test biomarkers for development of mild, moderate or severe disease

Sponsors

Region Skane
Lead SponsorOTHER
Lund University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Acute Pancreatitis, accept informed consent -

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Severe acute pancreatitis14 daysAccording 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

MeasureTime frameDescription
Moderately Severe Acute Pancreatitis14 daysAccording 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.

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORSara Regnér, MD, PhD

Region Skåne and Lund University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026