Subarachnoid HemorrhageSAH-CIPNCT05094349
Influence of Pneumonia on Delayed Cerebral Ischemia After Subarachnoid Hemorrhage . SAH-CIP (SubArrachnoid Hemorrhage - Cerebral Infarction Pneumonia)
An observational study of Subarachnoid Hemorrhage and Pneumonia, Bacterial, run by University Hospital, Brest at 1 site in France.
Trial summary
Prognosis of subarachnoid hemorrhage (SAH) is scarce, indeed almost half patients die or become severely disable after SAH. Outcome is related to the severity of the initial bleeding and delayed cerebral infarction (DCI). Infection and more precisely pneumonia have been associated with poor outcome in SAH. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage, Pneumonia, Bacterial
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2020to 15 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient admitted to ICU for subarachnoid hemorrhage (SAH). in our institution every patient diagnosed with non traumatic SAH are admitted for at least 24 hours in ICU.
Who may be able to join
- admitted in ICU in Brest University Hospital
- for non traumatic subarachnoid hemorrhage
- between july 2015 and december 2018
Who cannot join
- continuation of care out of Brest University Hospital after initial ICU stay
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Pneumonia on Delayed Cerebral Infarction After Subarachnoid Hemorrhage: a Retrospective Study
Prognosis of subarachnoid hemorrhage (SAH) is scarce, indeed almost half patients die or become severely disable after SAH. Outcome is related to the severity of the initial bleeding and delayed cerebral infarction (DCI). Infection and more precisely pneumonia have been associated with poor outcome in SAH. However, the interaction between the two pathologic events remains unclear. Therefore, we hypothesized that DCI may be associated to pneumonia in SAH patients. Thus the aim of the study is to analyze the association between delayed cerebral infarction and pneumonia in patients with SAH.
Retrospective, observational, monocentric cohort study, including patient admitted in Neurosurgical Intensive Care Unit or Surgical Intensive Care Unit in the University Hospital of Brest (France) for non-traumatic SAH. Primary outcome is diagnosis of DCI on CT scan or MRI 3 months after SAH. Multivariate analysis is used to identify factors independently associated with DCI.
We plan to include between 200 and 250 patients in the analysis.
- Conditions
- Subarachnoid Hemorrhage, Pneumonia, Bacterial
- Keywords
- Subarachnoid hemorrhage, pneumonia, delayed cerebral ischemia, vasospasm, delayed cerebral infarction
- Medical subject headings
- Subarachnoid Hemorrhage, Pneumonia, Bacterial, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed cerebral infarction
infarction on CT or MRI not related to initial bleeding
Measured: 3 months from subarachnoid hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start20 Feb 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
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 University Hospital, BrestThe 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
- Retrospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094349
- Sponsor's protocol ID
- SAH-CIP (29BRC19.0311)
- Acronym
- SAH-CIP
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pneumonia on Delayed Cerebral Infarction After Subarachnoid Hemorrhage: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05094349
- Acronym / sponsor ID
- SAH-CIP / SAH-CIP (29BRC19.0311)
- Conditions
- Subarachnoid Hemorrhage, Pneumonia, Bacterial
- Keywords
- Subarachnoid hemorrhage, pneumonia, delayed cerebral ischemia, vasospasm, delayed cerebral infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 26 Oct 2021 (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.
Prognosis of subarachnoid hemorrhage (SAH) is scarce, indeed almost half patients die or become severely disable after SAH. Outcome is related to the severity of the initial bleeding and delayed cerebral infarction (DCI). Infection and more precisely pneumonia have been associated with poor outcome in SAH. However, the interaction between the two pathologic events remains unclear. Therefore, we hypothesized that DCI may be associated to pneumonia in SAH patients. Thus the aim of the study is to analyze the association between delayed cerebral infarction and pneumonia in patients with SAH.
Retrospective, observational, monocentric cohort study, including patient admitted in Neurosurgical Intensive Care Unit or Surgical Intensive Care Unit in the University Hospital of Brest (France) for non-traumatic SAH. Primary outcome is diagnosis of DCI on CT scan or MRI 3 months after SAH. Multivariate analysis is used to identify factors independently associated with DCI.
We plan to include between 200 and 250 patients in the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient admitted to ICU for subarachnoid hemorrhage (SAH). in our institution every patient diagnosed with non traumatic SAH are admitted for at least 24 hours in ICU.
Key inclusion criteria (3 listed)
- admitted in ICU in Brest University Hospital
- for non traumatic subarachnoid hemorrhage
- between july 2015 and december 2018
Key exclusion criteria (2 listed)
- continuation of care out of Brest University Hospital after initial ICU stay
- refusal to participate
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
delayed cerebral infarction
Time frame: 3 months from subarachnoid hemorrhage
infarction on CT or MRI not related to initial bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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 and Pneumonia, Bacterial, run by University Hospital, Brest 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 3 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: finished, as of the sponsor's last update on 26 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
delayed cerebral infarction (time frame: 3 months from subarachnoid hemorrhage). 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 2021.