Subarachnoid HemorrhageSAHOT-FRNCT07894666
French Validation of the SAHOT Outcome Scale After Subarachnoid Haemorrhage
An observational study of Subarachnoid Hemorrhage, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Survivors of subarachnoid haemorrhage (SAH) frequently experience cognitive, psychological, physical and social sequelae, but no French-language instrument covers all these dimensions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2026to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a subarachnoid haemorrhage of any aetiology within the previous 12 months, seen at a follow-up consultation in the interventional neuroradiology department of the Hôpital Fondation Adolphe de Rothschild (Paris, France), and, when applicable, their accompanying relatives.
Who may be able to join
- Age over 18 years
- Subarachnoid haemorrhage of any aetiology
- Onset less than 12 months before inclusion
- Seen in consultation at the Hôpital Fondation Adolphe de Rothschild
- Judged able to complete a self-administered questionnaire by the evaluating clinician
- Informed and not opposed to participation (or relative's non-opposition if the patient is under guardianship and/or unable to consent)
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- Age over 18 years
- Relative / caregiver of a patient with subarachnoid haemorrhage within the previous 12 months
- Attending the follow-up consultation of an included patient
- Informed and not opposed to participation
Who cannot join
- Non-French-speaking
- Psychiatric disorder judged incompatible with completion of the questionnaires by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
About this study
Official title: Validation of the French Version of the Subarachnoid Haemorrhage Outcome Tool (SAHOT): a Prospective Single-Centre Cohort Study
Survivors of subarachnoid haemorrhage (SAH) frequently experience cognitive, psychological, physical and social sequelae, but no French-language instrument covers all these dimensions. The SAHOT (Subarachnoid Haemorrhage Outcome Tool), developed and validated in English, is a SAH-specific patient-reported outcome measure. This prospective single-centre cohort study aims to validate the French translation of the SAHOT in adult patients seen at a follow-up consultation within 12 months after a SAH of any aetiology. The primary objective is to assess the internal consistency of the French SAHOT. Seventy patients will be included; accompanying relatives may also be included to complete a proxy version of the questionnaire.
- Conditions
- Subarachnoid Hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal consistency of the French version of the SAHOT
Measured: At inclusion (follow-up consultation within 12 months after subarachnoid haemorrhage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start28 Sep 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894666
- Sponsor's protocol ID
- EGC_2025_12
- Acronym
- SAHOT-FR
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Subarachnoid Haemorrhage Outcome Tool (SAHOT): a Prospective Single-Centre Cohort Study
- ClinicalTrials.gov ID
- NCT07894666
- Acronym / sponsor ID
- SAHOT-FR / EGC_2025_12
- Conditions
- Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
Survivors of subarachnoid haemorrhage (SAH) frequently experience cognitive, psychological, physical and social sequelae, but no French-language instrument covers all these dimensions. The SAHOT (Subarachnoid Haemorrhage Outcome Tool), developed and validated in English, is a SAH-specific patient-reported outcome measure. This prospective single-centre cohort study aims to validate the French translation of the SAHOT in adult patients seen at a follow-up consultation within 12 months after a SAH of any aetiology. The primary objective is to assess the internal consistency of the French SAHOT. Seventy patients will be included; accompanying relatives may also be included to complete a proxy version of the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a subarachnoid haemorrhage of any aetiology within the previous 12 months, seen at a follow-up consultation in the interventional neuroradiology department of the Hôpital Fondation Adolphe de Rothschild (Paris, France), and, when applicable, their accompanying relatives.
Key inclusion criteria (10 listed)
- Age over 18 years
- Subarachnoid haemorrhage of any aetiology
- Onset less than 12 months before inclusion
- Seen in consultation at the Hôpital Fondation Adolphe de Rothschild
- Judged able to complete a self-administered questionnaire by the evaluating clinician
Key exclusion criteria (2 listed)
- Non-French-speaking
- Psychiatric disorder judged incompatible with completion of the questionnaires by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal consistency of the French version of the SAHOT
Time frame: At inclusion (follow-up consultation within 12 months after subarachnoid haemorrhage)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 10 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Gentric (+33 1 48 03 65 00 ext. 7260, egentric@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency of the French version of the SAHOT (time frame: At inclusion (follow-up consultation within 12 months after subarachnoid haemorrhage)). 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 26 Oct 2026.