Intracranial HemorrhagesHIDDENNCT06276517
Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom
An observational study of Intracranial Hemorrhages, run by Assistance Publique - Hôpitaux de Paris.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- questionnaire, SS-QoL and SF-36
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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,
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
Read the 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
- Intracranial Hemorrhages
- Being tested
- questionnaire, SS-QoL, SF-36, CIQ-R, BREFF
- Keywords
- post-HSA syndrome, subarachnoid hemorrhage
- Medical subject headings
- Intracranial Hemorrhages, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called Rivermead Post-Concussion symptoms questionnaire (RPQ)
self-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points.
SS-QoLOther
Also called qustionnaire
49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.).
SF-36Other
Also called questionnaire
multidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment
CIQ-ROther
Also called questionnaire
16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration
BREFFDiagnostic test
rapid frontal efficiency battery, 6 tests from 0 to 3 on each side
MoCADiagnostic test
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.
IADLOther
Also called questionnaire
8 questions rated from 0 to 1 to assess functional outcome
mMRSOther
Also called questionnaire
mMRS score from 0 to 4 to assess functional outcome
PCL-5Other
Also called questionnaire
To assess the prevalence of post-traumatic stress using the PCL-5 self-questionnaire. PCL-5 is a 20-item self-administered questionnaire.
Brief-CopeOther
Also called questionnaire
28-question self-questionnaires to study patients' coping strategies
| Study group | Role | What they receive |
|---|---|---|
| patients with subarachnoid hemorrhage | Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
- 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).
Measured: 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.
Measured: 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).
Measured: 3 months, 6 months and 1 year,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Why it stopped: absence of inclusion within two years of obtaining the CPP notice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276517
- Sponsor's protocol ID
- APHP220918
- Other IDs
- 2022-A01739-34
- Acronym
- HIDDEN
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom
- ClinicalTrials.gov ID
- NCT06276517
- Acronym / sponsor ID
- HIDDEN / APHP220918
- Conditions
- Intracranial Hemorrhages
- Keywords
- post-HSA syndrome, subarachnoid hemorrhage
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: absence of inclusion within two years of obtaining the CPP notice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with subarachnoid hemorrhage | – | 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-CopePatients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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,
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Motor deficits persisting 1 month after SAH
- Hospitalization > 1 month
- Patient does not speak French
- Patient with diagnosis of neurodegenerative disease.
- Traumatic meningeal hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireAlso: Rivermead Post-Concussion symptoms questionnaire (RPQ)self-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points. | Other | patients with subarachnoid hemorrhage |
| SS-QoLAlso: qustionnaire49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.). | Other | patients with subarachnoid hemorrhage |
| SF-36Also: questionnairemultidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment | Other | patients with subarachnoid hemorrhage |
| CIQ-RAlso: questionnaire16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration | Other | patients with subarachnoid hemorrhage |
| BREFFrapid frontal efficiency battery, 6 tests from 0 to 3 on each side | Diagnostic test | patients with subarachnoid hemorrhage |
| MoCAMoCA is a screening test for neurocognitive impairment. It comprises 11 categories scored from 0 to 6 for a total of 0 to 30 points. | Diagnostic test | patients with subarachnoid hemorrhage |
| IADLAlso: questionnaire8 questions rated from 0 to 1 to assess functional outcome | Other | patients with subarachnoid hemorrhage |
| mMRSAlso: questionnairemMRS score from 0 to 4 to assess functional outcome | Other | patients with subarachnoid hemorrhage |
| PCL-5Also: questionnaireTo assess the prevalence of post-traumatic stress using the PCL-5 self-questionnaire. PCL-5 is a 20-item self-administered questionnaire. | Other | patients with subarachnoid hemorrhage |
| Brief-CopeAlso: questionnaire28-question self-questionnaires to study patients' coping strategies | Other | patients with subarachnoid hemorrhage |
Primary outcome
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.
Time frame: 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.
3 secondary outcomes
- 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
Time frame: 3 months, 6 months and 1 year,
To study the prevalence of post-traumatic stress in this population
Time frame: 3 months, 6 months and 1 year,
Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire
Time frame: 3 months, 6 months and 1 year,
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhages, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.