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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06276517
Acronym
HIDDEN
Enrollment
80
Registered
2024-02-26
Start date
2024-03-31
Completion date
2028-03-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hemorrhages

Keywords

post-HSA syndrome, subarachnoid hemorrhage

Brief 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.

Interventions

OTHERquestionnaire

self-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points.

OTHERSS-QoL

49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.).

OTHERSF-36

multidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment

OTHERCIQ-R

16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration

DIAGNOSTIC_TESTBREFF

rapid frontal efficiency battery, 6 tests from 0 to 3 on each side

DIAGNOSTIC_TESTMoCA

MoCA is a screening test for neurocognitive impairment. It comprises 11 categories scored from 0 to 6 for a total of 0 to 30 points.

OTHERIADL

8 questions rated from 0 to 1 to assess functional outcome

OTHERmMRS

mMRS score from 0 to 4 to assess functional outcome

OTHERPCL-5

To assess the prevalence of post-traumatic stress using the PCL-5 self-questionnaire. PCL-5 is a 20-item self-administered questionnaire.

OTHERBrief-Cope

28-question self-questionnaires to study patients' coping strategies

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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.3 monthsThe 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.

Secondary

MeasureTime frameDescription
- 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 year3 months, 6 months and 1 year,Quality of life assessed using the SS-QoL questionnaire, specific to stroke patients. Self-questionnaire with 49 questions covering 12 domains (including work/productivity, mood, social roles, family roles, personality).
To study the prevalence of post-traumatic stress in this population3 months, 6 months and 1 year,Assess the prevalence of post-traumatic stress in this population using the PCL-5 self-questionnaire. PCL-5 is a 20-question self-questionnaire.
Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire3 months, 6 months and 1 year,Brief-Cope self-questionnaire (28-question self-questionnaires).

Contacts

Primary ContactLabeyrie Marc-Antoine
marc-antoine.labeyrie@aphp.fr01 49 95 83 52

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026