Acute PancreatitisAPKNCT05201053
Acute Pancreatitis and Coagulation Study
An observational study of Acute Pancreatitis, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Exploratory for different markers
- How many people
- 141 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2017to 1 Jun 2023
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted with Acute Pancreatitis at Skåne University Hospital in Malmö
Inclusion Criteria: Acute Pancreatitis, accept informed consent -
Exclusion Criteria: More than 72h from onset of symptoms until first sample, patient already included once
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coagulation Disturbances and Thrombosis in Acute Pancreatitis (Koagulopati Och Trombos Vid Akut Pankreatit-APK Studien)
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.
Read the 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.
- Conditions
- Acute Pancreatitis
- Being tested
- Exploratory for different markers
- Keywords
- Acute Pancreatitis, biomarkers, severity prediction
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploratory for different markersDiagnostic test
Test biomarkers for development of mild, moderate or severe disease
| Study group | Role | What they receive |
|---|---|---|
| Mild acute pancreatitis | Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients Receives: 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 Receives: 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 Receives: Diagnostic Test: Exploratory for different markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (1)
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 May 2017
- Primary completion31 May 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Sara Regnér, MD, PhD, Principal investigator, Region Skåne and Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201053
- Sponsor's protocol ID
- 2016/490
- Acronym
- APK
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publications. Upon request from other researchers or publishers with scientific interest and in accordance with GDPR regulations
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Disturbances and Thrombosis in Acute Pancreatitis (Koagulopati Och Trombos Vid Akut Pankreatit-APK Studien)
- ClinicalTrials.gov ID
- NCT05201053
- Acronym / sponsor ID
- APK / 2016/490
- Conditions
- Acute Pancreatitis
- Keywords
- Acute Pancreatitis, biomarkers, severity prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild acute pancreatitis | – | Diagnostic Test: Exploratory for different markersGroups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients |
| moderately severe acute pancreatitis | – | Diagnostic Test: Exploratory for different markersGroups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients |
| severe acute pancreatitis | – | Diagnostic Test: Exploratory for different markersGroups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted with Acute Pancreatitis at Skåne University Hospital in Malmö
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exploratory for different markersTest biomarkers for development of mild, moderate or severe disease | Diagnostic test | Mild acute pancreatitis, moderately severe acute pancreatitis, severe acute pancreatitis |
Primary outcome
Severe acute pancreatitis
Time frame: 14 days
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.
1 secondary outcome
Moderately Severe Acute Pancreatitis
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. After publications. Upon request from other researchers or publishers with scientific interest and in accordance with GDPR regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Regnér, MD, PhD principal investigator
Region Skåne and Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe acute pancreatitis (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.