Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT06276517

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

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERquestionnaireself-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points.
OTHERSS-QoL49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.).
OTHERSF-36multidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment
OTHERCIQ-R16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration
DIAGNOSTIC_TESTBREFFrapid frontal efficiency battery, 6 tests from 0 to 3 on each side
DIAGNOSTIC_TESTMoCAMoCA is a screening test for neurocognitive impairment. It comprises 11 categories scored from 0 to 6 for a total of 0 to 30 points.
OTHERIADL8 questions rated from 0 to 1 to assess functional outcome
OTHERmMRSmMRS score from 0 to 4 to assess functional outcome
OTHERPCL-5To assess the prevalence of post-traumatic stress using the PCL-5 self-questionnaire. PCL-5 is a 20-item self-administered questionnaire.
OTHERBrief-Cope28-question self-questionnaires to study patients' coping strategies

Timeline

Start date
2024-03-01
Primary completion
2028-03-01
Completion
2028-03-01
First posted
2024-02-26
Last updated
2026-04-06

Source: ClinicalTrials.gov record NCT06276517. Inclusion in this directory is not an endorsement.