跳至主要内容
临床试验/NCT04624945
NCT04624945招募中不适用

DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE (The DISSIPATE Study)

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
To validate the use of APTT CWA and ICIS, as early sepsis markers for neurosurgical ICU patients suffering subarachnoid haemorrhage, traumatic brain injury and other intracranial haemorrhages.

研究概览

简要总结

The research study is to explore novel early predictors and validation of laboratory parameters in the management of sepsis in critically ill patients especially with brain injuries and systemic inflammatory response syndrome (SIRS).

详细描述

This is a prospective observational study. 150 subjects with the admission diagnosis of neurological haemorrhage (e.g. subarachnoid haemorrhage, intracerebral haemorrhage etc), admitted to SICU of National University Hospital, Singapore, who are expected to stay for more than 48 hours, will be recruited and enrolled. No adverse events are expected as a result of this study as patients do not deviate from the current standard of care. Frequency of blood sampling will be stipulated at day 1/2/3/4/5 to draw clinical relevance. An additional 0.5 tablespoonful (7.7ml) of blood will be taken daily from each subject as well as residual blood from routine laboratory test blood samples. In total, an additional volume of 2.5 tablespoonful (38.5ml) of blood will be collected from each subject over a period of 5 days. Residual blood refers to any leftover blood samples collected for routine laboratory tests which will be shared and used to carry out additional blood tests. All ICU patients will have arterial lines inserted as part of routine care, so there will not be pain from the blood sampling. In the current study, measurements will be made on the routine laboratory haematology, coagulation and immunoassay analyzers. Research blood parameters that are not usually reported as indicated in the background section will be used for the correlation and association analysis to sepsis. In addition, the study team will also be collecting clinical and demographic data of recruited subjects from medical records for purposes of this study.

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
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 21 years and above
  • Clinical/radiological suspicion or confirmation of neurological haemorrhage

排除标准

  • Age below 21 years
  • Prisoners
  • Known pregnancy
  • Do-not-attempt resuscitation status
  • Requirement for immediate surgery
  • Active chemotherapy/neutropenia (Neutrophil count <1.0 x 109/L)
  • Immuno-compromised
  • Haematological malignancy
  • Treating physician deems aggressive care unsuitable
  • Unable to provide informed consent or comply with study requirements

结局指标

主要结局

To validate the use of APTT CWA and ICIS, as early sepsis markers for neurosurgical ICU patients suffering subarachnoid haemorrhage, traumatic brain injury and other intracranial haemorrhages.

时间窗: SICU stay from day 1 to day 5 through to 2 years of blood test completion

Activated Partial Thromboplastin Time (APTT) clot waveform analysis (CWA) by flow cytometry-based method

次要结局

  • To examine the evolution of CWA, immuno-parameters (KL-6, SP-A, MIG, presepsin) and various WBC activation markers over the time in relation to diagnosis of sepsis, development of positive blood cultures and mortality or recovery.(SICU stay from day 1 to day 5 through to 2 years of blood test completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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