Clinical trial NCT02373293: Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC)
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Keywords: Acute pancreatitis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Alclinical Research, S.L.
First posted: 2015-02-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with mild acute pancreatitis

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with exacerbated chronic pancreatitis.
* Patients with coagulation disorders (congenital and acquired antithrombin deficiency) .
* Patients with liver cirrhosis.
* Pregnant patients

Primary outcomes:
measure: antithrombin III levels vs maximum seriousness grade of acute pancreatitis
timeFrame: At Admission and at 24h
Secondary outcomes:
measure: result of modified Marshall and Apache II scales
timeFrame: Admission and at 24h
measure: antithrombin III levels vs mortality
timeFrame: From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"
measure: antithrombin III levels vs organic failure
timeFrame: From date of admission until the end of study or date of organic failure, whichever came first, assessed up to 1 month"
measure: antithrombin III levels vs necrosis and infection rates
timeFrame: From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisés Broggi
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Francisco Javier García Borobia, Dr.
role: PRINCIPAL_INVESTIGATOR
References: