Acute PancreatitisAT-PROPANCNCT02373293
Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC)
An observational study of Acute Pancreatitis, run by Francisco Javier García Borobia at 2 sites in Spain.
Trial summary
This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 400 participants
- Where
- 2 sitesSpain
- Study dates
- 18 Jan 2015to 31 Aug 2017
- 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: Adult patients with mild acute pancreatitis
Who may be able to join
- Patients diagnosed with mild acute pancreatitis according to seriousness criteria established by Banks et al, 2013.
- Patients of either sex aged ≥ 18 years .
- Patients who have given their written informed consent
Who cannot join
- Patients with exacerbated chronic pancreatitis.
- Patients with coagulation disorders (congenital and acquired antithrombin deficiency) .
- Patients with liver cirrhosis.
- Pregnant patients
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Francisco Javier -García Borobia, Dr., +34 93 7231010 ext. 21461, fjgarcia@tauli.cat
Francisco Javier García Borobia, Dr.
- Recruiting
Hospital de Sant Joan Despí Moisés Broggi
Sant Joan Despí, Barcelona, 08970
Robert Memba, Dr.
Robert Memba, Dr.
About this study
Official title: Epidemiologic , Observational, Prospective Study to Assess the Prognostic Value of the Antithrombin III in the Development of Moderate or Severe Acute Pancreatitis (AT-PROPANC)
This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.
Read the detailed description
This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.
In the context of clinical practice of general surgery and apparatus digestive services, patients entering with mild acute pancreatitis will be asked to participate in the study and if so, they will sign the informed consent.
On admission, demographic and anthropometric data of the patient will be recorded, as well as medical history, patient's admission data and vital signs. Patient's blood will be drawn for analysys and the risk of organ failure will be measured by modified Marshall and Apache II scales. The assessments and procedures performed are the standard practice at the center.
At 24 hours (± 3 hours) and at 7 days (or nine days to avoid weekends) after admisison, vital signs will be recorded, laboratory tests will be performed and the risk of organ failure will be measured by modified Marshall and Apache II scales.
At discharge of the patient (regardless of when it occurs), the outcome of the acute pancreatitis will be recorded.
. Those patients discharged within the first month after admission will be visited or called (according to standard practice at the center) one month after arrival, to record follow-up data, including health condition, readmissions and abdominal pain evaluation by visual analog scale.
- Conditions
- Acute Pancreatitis
- Keywords
- Acute pancreatitis
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
antithrombin III levels vs maximum seriousness grade of acute pancreatitis
Levels of antithrombin III at admission and at 24h will be related with maximum seriousness grade of acute pancreatitis reached during patient's admission at site by logistic regression models
Measured: At Admission and at 24h
Secondary outcomes (4)
result of modified Marshall and Apache II scales
Measured: Admission and at 24h
antithrombin III levels vs mortality
Levels of antithrombin III at admission and at 24h will be related with mortality rates by logistic regression models
Measured: From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"
antithrombin III levels vs organic failure
Levels of antithrombin III at admission and at 24h will be related with organic failure rates by logistic regression models
Measured: From date of admission until the end of study or date of organic failure, whichever came first, assessed up to 1 month"
antithrombin III levels vs necrosis and infection rates
Levels of antithrombin III at admission and at 24h will be related with necrosis and infection rates by logistic regression models
Measured: From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start18 Jan 2015
- Primary completion30 Jan 2015
- Study completion31 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Javier García Borobia
- Sponsor type
- University, hospital or other
- Collaborators
- Alclinical Research, S.L.
- Responsible party
- Sponsor-investigator, Francisco Javier García Borobia, Corporacion Parc Tauli
- Investigators
- Francisco Javier García Borobia, Dr., Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373293
- Sponsor's protocol ID
- GAR-BOR/TAULI-2013
- Acronym
- AT-PROPANC
- Status last verified
- Jul 2017
- First submitted
- 20 Feb 2015
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia Borobia F, Flores Clotet R, Bejarano Gonzalez N, Gonzalez Martinez S, Garcia Monforte N, Romaguera Monzonis A, Gonzalez Abos C, Gonzalez Abos S, Lucas Guerrero V, Perez Perarnau A, Mota Villaplana F. Predictive Value of Antithrombin III and d -Dimer in the Development of Moderate-To-Severe Acute Pancreatitis : A Prospective, Observational Study (AT-PROPANC). Pancreas. 2023 Apr 1;52(4):e241-e248. doi: 10.1097/MPA.0000000000002245. Epub 2023 Sep 20.
PubMed 37801622
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic , Observational, Prospective Study to Assess the Prognostic Value of the Antithrombin III in the Development of Moderate or Severe Acute Pancreatitis (AT-PROPANC)
- ClinicalTrials.gov ID
- NCT02373293
- Acronym / sponsor ID
- AT-PROPANC / GAR-BOR/TAULI-2013
- Conditions
- Acute Pancreatitis
- Keywords
- Acute pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Francisco Javier García BorobiaUniversity, hospital or other
- Collaborators
- Alclinical Research, S.L.
- Study start
- 18 Jan 2015
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- 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.
This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.
Detailed description
This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.
In the context of clinical practice of general surgery and apparatus digestive services, patients entering with mild acute pancreatitis will be asked to participate in the study and if so, they will sign the informed consent.
On admission, demographic and anthropometric data of the patient will be recorded, as well as medical history, patient's admission data and vital signs. Patient's blood will be drawn for analysys and the risk of organ failure will be measured by modified Marshall and Apache II scales. The assessments and procedures performed are the standard practice at the center.
At 24 hours (± 3 hours) and at 7 days (or nine days to avoid weekends) after admisison, vital signs will be recorded, laboratory tests will be performed and the risk of organ failure will be measured by modified Marshall and Apache II scales.
At discharge of the patient (regardless of when it occurs), the outcome of the acute pancreatitis will be recorded.
. Those patients discharged within the first month after admission will be visited or called (according to standard practice at the center) one month after arrival, to record follow-up data, including health condition, readmissions and abdominal pain evaluation by visual analog scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with mild acute pancreatitis
Key inclusion criteria (3 listed)
- Patients diagnosed with mild acute pancreatitis according to seriousness criteria established by Banks et al, 2013.
- Patients of either sex aged ≥ 18 years .
- Patients who have given their written informed consent
Key exclusion criteria (4 listed)
- Patients with exacerbated chronic pancreatitis.
- Patients with coagulation disorders (congenital and acquired antithrombin deficiency) .
- Patients with liver cirrhosis.
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
antithrombin III levels vs maximum seriousness grade of acute pancreatitis
Time frame: At Admission and at 24h
Levels of antithrombin III at admission and at 24h will be related with maximum seriousness grade of acute pancreatitis reached during patient's admission at site by logistic regression models
4 secondary outcomes
result of modified Marshall and Apache II scales
Time frame: Admission and at 24h
antithrombin III levels vs mortality
Time frame: From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"
antithrombin III levels vs organic failure
Time frame: From date of admission until the end of study or date of organic failure, whichever came first, assessed up to 1 month"
antithrombin III levels vs necrosis and infection rates
Time frame: From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Derived from this study: PubMed 37801622Garcia Borobia F, Flores Clotet R, Bejarano Gonzalez N, Gonzalez Martinez S, Garcia Monforte N, Romaguera Monzonis A, Gonzalez Abos C, Gonzalez Abos S, Lucas Guerrero V, Perez Perarnau A, Mota Villaplana F. Predictive Value of Antithrombin III and d -Dimer in the Development of Moderate-To-Severe Acute Pancreatitis : A Prospective, Observational Study (AT-PROPANC). Pancreas. 2023 Apr 1;52(4):e241-e248. doi: 10.1097/MPA.0000000000002245. Epub 2023 Sep 20.
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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.
Francisco Javier García Borobia, Dr. principal investigator
Corporacion Parc Tauli
2 sites 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 Francisco Javier García Borobia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier García Borobia, Dr. (+34 93 7231010 ext. 21461, fjgarcia@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antithrombin III levels vs maximum seriousness grade of acute pancreatitis (time frame: At Admission and at 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373293, which also lists 1 linked publication.
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 28 Jul 2017.