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临床试验/NCT06276517
NCT06276517撤回不适用

Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 80 人开始时间: 2024年3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
撤回
入组人数
80
主要终点
Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome.

研究概览

简要总结

Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire

详细描述

Every year, subarachnoid hemorrhage affects 9.1 people per 100,000 worldwide, with a peak between the ages of 50 and 60. Its frequency and relatively young age of onset make it a major source of decline in healthy life years.

Progress over the past thirty years has led to a 57% reduction in mortality, but these figures do not always reflect the day-to-day reality of these patients, for whom recovery remains incomplete in almost half of cases. For example, a third of patients have not returned to work at one year, and of those who have, only half have returned to work full-time. In 2020, a Norwegian team showed that, at one year, a third of patients suffer from a "post-HSA syndrome", as yet little described, but which seems very similar to the post-concussion syndrome experienced by patients after head trauma. In their study, only 3% of patients with this syndrome returned to work at one year. A better understanding of the incidence of this syndrome, as well as its evolution and determinants, is therefore essential.

With this in mind, the investigators chose to assess the presence of post-SAH syndrome at 3 months and its repercussions on return to work, using the Rivermead questionnaire.

Secondly, in view of the prevalence of post-traumatic stress syndrome at 3 years (a quarter of patients), the investigators wished to study the factors determining the presence of post-HSA syndrome and an inability to return to work at 3 months, 6 months, 1 year.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 to 65
  • Patient hospitalized in intensive care unit at Hôpital Lariboisière between September 2022 and September 2023 for subarachnoid hemorrhage due to aneurysmal rupture.
  • Patient affiliated to the French social security system
  • Patient expressing no objection

排除标准

  • Motor deficits persisting 1 month after SAH
  • Hospitalization > 1 month
  • Patient does not speak French
  • Patient with diagnosis of neurodegenerative disease.
  • Traumatic meningeal hemorrhage
  • Patients on AME

研究组 & 干预措施

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: questionnaire (Other)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: SS-QoL (Other)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: SF-36 (Other)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: CIQ-R (Other)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: BREFF (Diagnostic Test)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: MoCA (Diagnostic Test)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: IADL (Other)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: mMRS (Other)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: PCL-5 (Other)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

干预措施: Brief-Cope (Other)

结局指标

主要结局

Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome.

时间窗: 3 months

The Rivermead questionnaire is a 16-item self-administered questionnaire, rated from 0 to 4, giving a total of 0 to 52 points. This scale was created to assess post-concussion syndrome, which in many ways is similar to what patients experience after a SAH. The higher the score, the greater the difficulties experienced by the patient. A score of 3 or 4 for any of the responses indicates that the patient is incapacitated.

次要结局

  • Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire(3 months, 6 months and 1 year,)
  • - study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year(3 months, 6 months and 1 year,)
  • To study the prevalence of post-traumatic stress in this population(3 months, 6 months and 1 year,)

研究者

申办方类型
Other
责任方
Sponsor

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