Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC) (AT-PROPANC)

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Francisco Javier García Borobia, Dr.; Phone Number: 21461 +34 93 7231010; Email: fjgarcia@tauli.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Corporacio Sanitaria Parc Tauli
      • Contact: Francisco Javier -García Borobia, Dr.; Phone Number: 21461 +34 93 7231010; Email: fjgarcia@tauli.cat
      • Principal Investigator: Francisco Javier García Borobia, Dr.
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Recruiting
      • Hospital de Sant Joan Despí Moisès Broggi
      • Contact: Robert Memba, Dr.
      • Principal Investigator: Robert Memba, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with mild acute pancreatitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At Admission and at 24h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
result of modified Marshall and Apache II scales		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	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	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	From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"

Collaborators and Investigators

• Sponsor: Francisco Javier García Borobia
• Collaborators: Alclinical Research, S.L.
• Investigators: Principal Investigator: Francisco Javier García Borobia, Dr., Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start: January 18, 2015
• Primary Completion (Actual): January 30, 2015
• Study Completion (Anticipated): August 31, 2017

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Acute pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: GAR-BOR/TAULI-2013