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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

Tracking Information
First Submitted Date February 20, 2015
First Posted Date February 27, 2015
Last Update Posted Date July 28, 2017
Study Start Date January 18, 2015
Actual Primary Completion Date January 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2015)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02373293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 26, 2015)
  • result of modified Marshall and Apache II scales [ Time Frame: Admission and at 24h ]
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (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)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients with mild acute pancreatitis
Condition Acute Pancreatitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 26, 2015)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2017
Actual Primary Completion Date January 30, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02373293
Other Study ID Numbers GAR-BOR/TAULI-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Francisco Javier García Borobia, Corporacion Parc Tauli
Study Sponsor Francisco Javier García Borobia
Collaborators Alclinical Research, S.L.
Investigators
Principal Investigator: Francisco Javier García Borobia, Dr. Corporacion Parc Tauli
PRS Account Corporacion Parc Tauli
Verification Date July 2017