跳至主要内容
临床试验/NCT03895736
NCT03895736已完成不适用

" Etude du Transcriptome Complet Lors du Syndrome Post-arrêt Cardiaque " Transcriptome Assessment After Cardiac Arrest

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Early Transcriptome at hospital admission

研究概览

简要总结

The purpose of this study is to determine whether the blood transcriptome of patients resuscitated after out-of-hospital could be an early predictor of the neurological outcome.

详细描述

Assessing the prognosis of the patients resuscitated after out-of-hospital cardiac arrest (OHCA) is still highly challenging. Beyond usual neurological markers, experimental and clinical studies have also shown that blood levels of several cytokines or miRNA could be significantly different after cardiac arrest in subjects prematurely died as compared to survivors with a good neurological recovery. Here the investigators propose to investigate a screening approach assessing simultaneously multiple targets of the post-cardiac arrest syndrome through analysis of the whole transcriptome of patients after OHCA. For this purpose, the investigators will collect blood samples from 60 patients after admission at hospital and then 1 and 3 days later. The Pittsburgh Cerebral Performance Category of each patient will be evaluated for each patient at day 60 after cardiac arrest. At the end of the collection period, the blood samples will be prepared for whole genome analysis and RNA sequencing. The primary analysis of the investigators will be the comparison of the transcriptome at day 0 after cardiac arrest in patients reaching Cerebral Performance Category (CPC) 1 at day 60 as compared to all other patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 80 years
  • Delay between patients collapse and resumption of spontaneous circulation (ROSC) < 60 minutes
  • Comatose patients ROSC with Glasgow score < 7
  • Patient already registered in the social security system
  • Consent of a family member, if able to understand in the emergency context, or attestation of emergency situation with a follow-up information notice

排除标准

  • Cardiac arrest supposed to be provoked by trauma or sepsis

结局指标

主要结局

Early Transcriptome at hospital admission

时间窗: Day 0

Blood samples will be collected for each patient early after admission at hospital and blood whole transcriptome will be assessed by RNA sequencing

Pittsburgh Cerebral Performance Category at Day 60

时间窗: Day 60

Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60

次要结局

  • Number of participants with death at day 60(day 60)
  • Transcriptome at day 3(Day 3)
  • Pittsburgh Cerebral Performance Category at Day 28(day 28)
  • Transcriptome at day 1(Day 1)
  • Number of participants with death at day 28(day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验