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

NCT02373293 | Unknown

• 1 other identifier: GAR-BOR/TAULI-2013
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Pancreatitis

Keywords

Acute pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• result of modified Marshall and Apache II scales

  Admission and at 24h

• antithrombin III levels vs mortality

  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

  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

  From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with mild acute pancreatitis

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Francisco Javier García Borobia: lead
• Alclinical Research, S.L.: collaborator

Study Sites (2)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital de Sant Joan Despí Moisés Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 37801622 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Francisco Javier García Borobia, Dr.

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Javier García Borobia, Dr.

CONTACT

+34 93 7231010; fjgarcia@tauli.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 27, 2015
• Study Start: January 18, 2015
• Primary Completion: January 30, 2015
• Study Completion: August 31, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

ES (2)