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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Hemorrhages
• Intervention / Treatment: Other: questionnaire; Other: SS-QoL; Other: SF-36; Other: CIQ-R; Diagnostic test: BREFF; Diagnostic test: MoCA; Other: IADL; Other: mMRS; Other: PCL-5; Other: Brief-Cope

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Labeyrie Marc-Antoine; Phone Number: 01 49 95 83 52; Email: marc-antoine.labeyrie@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 65 who had presented with an episode of spontaneous subarachnoid haemorrhage or aneurysmal rupture, excluding meningeal haemorrhage due to trauma,

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients with subarachnoid hemorrhage; Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

Other: questionnaire; self-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points.; Other Names: Rivermead Post-Concussion symptoms questionnaire (RPQ); Other: SS-QoL; 49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.).; Other Names: qustionnaire; Other: SF-36; multidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment; Other Names: questionnaire; Other: CIQ-R; 16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration; Other Names: questionnaire; Diagnostic test: BREFF; rapid frontal efficiency battery, 6 tests from 0 to 3 on each side; Diagnostic test: 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; Other Names: questionnaire; Other: mMRS; mMRS score from 0 to 4 to assess functional outcome; Other Names: questionnaire; Other: 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.; Other Names: questionnaire; Other: Brief-Cope; 28-question self-questionnaires to study patients' coping strategies; Other Names: questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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,
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,
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,

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: subarachnoid hemorrhage; post-HSA syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages; Subarachnoid Hemorrhage
• Other Study ID Numbers: APHP220918; 2022-A01739-34 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No