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

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ClinicalTrials.gov Identifier: NCT02373293
Recruitment Status : Unknown
Verified July 2017 by Francisco Javier García Borobia, Corporacion Parc Tauli.
Recruitment status was:  Recruiting
First Posted : February 27, 2015
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
Alclinical Research, S.L.
Information provided by (Responsible Party):
Francisco Javier García Borobia, Corporacion Parc Tauli

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.

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : January 18, 2015
Actual Primary Completion Date : January 30, 2015
Estimated Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis




Primary Outcome Measures :
  1. antithrombin III levels vs maximum seriousness grade of acute pancreatitis [ Time Frame: 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 :
  1. result of modified Marshall and Apache II scales [ Time Frame: Admission and at 24h ]
  2. antithrombin III levels vs mortality [ Time Frame: 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

  3. antithrombin III levels vs organic failure [ Time Frame: 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

  4. antithrombin III levels vs necrosis and infection rates [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with mild acute pancreatitis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373293


Contacts
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Contact: Francisco Javier García Borobia, Dr. +34 93 7231010 ext 21461 fjgarcia@tauli.cat

Locations
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Spain
Corporació Sanitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Francisco Javier -García Borobia, Dr.    +34 93 7231010 ext 21461    fjgarcia@tauli.cat   
Principal Investigator: Francisco Javier García Borobia, Dr.         
Hospital de Sant Joan Despí Moisés Broggi Recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Contact: Robert Memba, Dr.         
Principal Investigator: Robert Memba, Dr.         
Sponsors and Collaborators
Francisco Javier García Borobia
Alclinical Research, S.L.
Investigators
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Principal Investigator: Francisco Javier García Borobia, Dr. Corporacion Parc Tauli

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Responsible Party: Francisco Javier García Borobia, Dr., Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02373293     History of Changes
Other Study ID Numbers: GAR-BOR/TAULI-2013
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Keywords provided by Francisco Javier García Borobia, Corporacion Parc Tauli:
Acute pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants