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

• Conditions: Acute Pancreatitis

• Registration Number: NCT02373293
• Lead Sponsor: Francisco Javier García Borobia

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.

Study Timeline

• Study Start: 2015-01-18
• Primary Completion: 2015-01-30
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28
• Study Completion: 2017-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
antithrombin III levels vs maximum seriousness grade of acute pancreatitis	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

Secondary Outcome Measures

Name	Time	Method
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"	Levels of antithrombin III at admission and at 24h will be related with mortality rates by logistic regression models
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"	Levels of antithrombin III at admission and at 24h will be related with organic failure rates by logistic regression models
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"	Levels of antithrombin III at admission and at 24h will be related with necrosis and infection rates by logistic regression models

Trial Locations

Locations (2)

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de Sant Joan Despí Moisés Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain