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

Acute Pancreatitis Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02373293
• Other study ID #: GAR-BOR/TAULI-2013
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2015
• Last updated: July 26, 2017
• Start date: January 18, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: July 2017
• Source: Corporacion Parc Tauli
• Contact: Francisco Javier García Borobia, Dr.
• Phone: +34 93 7231010
• Email: fjgarcia[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2017
• Est. primary completion date: January 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital de Sant Joan Despí Moisés Broggi	Sant Joan Despí	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Francisco Javier García Borobia	Alclinical Research, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	result of modified Marshall and Apache II scales		Admission and at 24h
Secondary	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"
Secondary	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"
Secondary	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"