Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC) (AT-PROPANC)
Epidemiologic , Observational, Prospective Study to Assess the Prognostic Value of the Antithrombin III in the Development of Moderate or Severe Acute Pancreatitis (AT-PROPANC)
研究概览
地位
条件
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Francisco Javier García Borobia, Dr.
- 电话号码：21461 +34 93 7231010
- 邮箱：fjgarcia@tauli.cat
学习地点
-
-
Barcelona
-
Sabadell、Barcelona、西班牙、08208
- 招聘中
- Corporació Sanitària Parc Taulí
-
接触：
- Francisco Javier -García Borobia, Dr.
- 电话号码：21461 +34 93 7231010
- 邮箱：fjgarcia@tauli.cat
-
首席研究员：
- Francisco Javier García Borobia, Dr.
-
Sant Joan Despí、Barcelona、西班牙、08970
- 招聘中
- Hospital de Sant Joan Despí Moisès Broggi
-
接触：
- Robert Memba, Dr.
-
首席研究员：
- Robert Memba, Dr.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
antithrombin III levels vs maximum seriousness grade of acute pancreatitis
大体时间：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
|
At Admission and at 24h
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
result of modified Marshall and Apache II scales
大体时间：Admission and at 24h
|
Admission and at 24h
|
|
|
antithrombin III levels vs mortality
大体时间：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
|
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
大体时间：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
|
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
大体时间：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
|
From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"
|
合作者和调查者
调查人员
- 首席研究员：Francisco Javier García Borobia, Dr.、Corporacion Parc Tauli
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.