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

Intracranial Hemorrhages Clinical Trial

— HIDDEN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276517
• Other study ID #: APHP220918
• Secondary ID: 2022-A01739-34
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: March 2028

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Labeyrie Marc-Antoine
• Phone: 01 49 95 83 52
• Email: marc-antoine.labeyrie[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages
• Subarachnoid Hemorrhage

Intervention

Other:
• questionnaire
self-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points.
• SS-QoL
49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.).
• SF-36
multidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment
• CIQ-R
16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration

Diagnostic Test:
• BREFF
rapid frontal efficiency battery, 6 tests from 0 to 3 on each side
• MoCA
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.

Other:
• IADL
8 questions rated from 0 to 1 to assess functional outcome
• mMRS
mMRS score from 0 to 4 to assess functional outcome
• PCL-5
To assess the prevalence of post-traumatic stress using the PCL-5 self-questionnaire. PCL-5 is a 20-item self-administered questionnaire.
• Brief-Cope
28-question self-questionnaires to study patients' coping strategies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 months
Secondary	- 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	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).	3 months, 6 months and 1 year,
Secondary	To study the prevalence of post-traumatic stress in this population	Assess the prevalence of post-traumatic stress in this population using the PCL-5 self-questionnaire. PCL-5 is a 20-question self-questionnaire.	3 months, 6 months and 1 year,
Secondary	Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire	Brief-Cope self-questionnaire (28-question self-questionnaires).	3 months, 6 months and 1 year,