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临床试验/NCT05201053
NCT05201053已完成不适用

Coagulation Disturbances and Thrombosis in Acute Pancreatitis (Koagulopati Och Trombos Vid Akut Pankreatit-APK Studien)

Region Skane2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
141
试验地点
2
主要终点
Severe acute pancreatitis

研究概览

简要总结

The study aims to investigate pathophysiological changes in coagulation in relation to inflammation in patients with acute pancreatitis. Serum and plasma is sampled repeated days from admission. Analysis will be done after recruitment. Specific biomarkers accuracy for prediction of moderate and severer acute pancreatitis will be calculated.

详细描述

Inclusion criteria:

Patients with acute pancreatitis admitted to Skåne University Hospital in Malmö

Acute pancreatitis is defined as minimum 2 out of following: amylase levels >3 times upper reference limit, clinical signs of acute pancreatitis, imaging findings of acute pancreatitis)

Exclusion criteria:

<18 years of age

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute Pancreatitis, accept informed consent -

排除标准

  • More than 72h from onset of symptoms until first sample, patient already included once

研究组 & 干预措施

Mild acute pancreatitis

Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients

干预措施: Exploratory for different markers (Diagnostic Test)

moderately severe acute pancreatitis

Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients

干预措施: Exploratory for different markers (Diagnostic Test)

severe acute pancreatitis

Groups are defined by the Revised Atlanta classification. Anticipated 60% mild, 30% moderate and 10% severe patients

干预措施: Exploratory for different markers (Diagnostic Test)

结局指标

主要结局

Severe acute pancreatitis

时间窗: 14 days

According to Revised Atlanta which is a consensus document where organ failure (defined by modified Marshall score) less than 48hours or signs of local complications on CT scan defines severity. This is not a scale but a generally used definition according to the paper: Banks PA, et al. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013;62(1):102-11.

次要结局

  • Moderately Severe Acute Pancreatitis(14 days)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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