Traumatic Intracranial Subarachnoid HemorrhageNCT06136078
Appropriateness of Methodist Health System(MHS) Inter-facility Transfers of Traumatic Intracranial Subarachnoid Hemorrhage and Spontaneous Bleeds for Level-1 Advanced Surgical Intervention
An observational study of Traumatic Intracranial Subarachnoid Hemorrhage, run by Methodist Health System at 1 site in United States.
Trial summary
Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Intracranial Subarachnoid Hemorrhage
- What is being tested?
- rate of appropriate and inappropriate transfers from Methodist interfacility transfers
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 20 Jun 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Methodist Mansfield Medical Center and Methodist Charlton Medical Center to Methodist Dallas Medical Center for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleeds
Who may be able to join
- Patients ≥18 years old
- Diagnosed with traumatic intracranial subarachnoid hemorrhage or a spontaneous bleed
- Patients originating at Methodist Mansfield medical center (MMMC) or Methodist Charlton medical center(MCMC)and subsequently transferred to Methodist Dallas medical center (MDMC)
Who cannot join
- Does not meet inclusion criteria defined in section 3.1
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
Bethany N Brauer, MPH, 410-947-4681 ext. 74681, Bethanybrauer@mhd.com
Loretta W Bedell, MPH, 214-947-4680 ext. 74680, lorettabedell@mhd.com
About this study
Official title: Appropriateness of MHS Inter-facility Transfers of Traumatic Intracranial Subarachnoid Hemorrhage and Spontaneous Bleeds for Level-1 Advanced Surgical Intervention
Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment.
Read the detailed description
Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment. Depending on the indication and its severity, transfer to a comprehensive stroke center for access to advanced neuro-critical care may be necessary. Comprehensive stroke centers are widely supported and have the resources and infrastructure to have in-house expert stroke providers, teams, operating rooms, and interventional radiology suites that are always available.
- Being tested
- rate of appropriate and inappropriate transfers from Methodist interfacility transfers
- Medical subject headings
- Subarachnoid Hemorrhage, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rate of appropriate and inappropriate transfers from Methodist interfacility transfersOther
Evaluating rate for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleeds
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the historical rate of appropriate and inappropriate Methodist interfacility transfers for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleed.
Implementation of screening protocols and standardization for interfacility transfers may help to reduce the incidence of unnecessary transfers.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Jun 2022
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Intracranial Subarachnoid HemorrhageStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Meyrat, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136078
- Sponsor's protocol ID
- 101.MBSI.2022.A
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
Publications
Alan N, Kim S, Agarwal N, Clarke J, Yealy DM, Cohen-Gadol AA, Sekula RF. Inter-facility transfer of patients with traumatic intracranial hemorrhage and GCS 14-15: The pilot study of a screening protocol by neurosurgeon to avoid unnecessary transfers. J Clin Neurosci. 2020 Nov;81:246-251. doi: 10.1016/j.jocn.2020.09.050. Epub 2020 Oct 15.
PubMed 33222924
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriateness of MHS Inter-facility Transfers of Traumatic Intracranial Subarachnoid Hemorrhage and Spontaneous Bleeds for Level-1 Advanced Surgical Intervention
- ClinicalTrials.gov ID
- NCT06136078
- Acronym / sponsor ID
- 101.MBSI.2022.A
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment.
Detailed description
Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment. Depending on the indication and its severity, transfer to a comprehensive stroke center for access to advanced neuro-critical care may be necessary. Comprehensive stroke centers are widely supported and have the resources and infrastructure to have in-house expert stroke providers, teams, operating rooms, and interventional radiology suites that are always available.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Methodist Mansfield Medical Center and Methodist Charlton Medical Center to Methodist Dallas Medical Center for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleeds
Key inclusion criteria (3 listed)
- Patients ≥18 years old
- Diagnosed with traumatic intracranial subarachnoid hemorrhage or a spontaneous bleed
- Patients originating at Methodist Mansfield medical center (MMMC) or Methodist Charlton medical center(MCMC)and subsequently transferred to Methodist Dallas medical center (MDMC)
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria defined in section 3.1
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 |
|---|---|---|
| rate of appropriate and inappropriate transfers from Methodist interfacility transfersEvaluating rate for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleeds | Other | – |
Primary outcome
To determine the historical rate of appropriate and inappropriate Methodist interfacility transfers for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleed.
Time frame: 3 days
Implementation of screening protocols and standardization for interfacility transfers may help to reduce the incidence of unnecessary transfers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 33222924Alan N, Kim S, Agarwal N, Clarke J, Yealy DM, Cohen-Gadol AA, Sekula RF. Inter-facility transfer of patients with traumatic intracranial hemorrhage and GCS 14-15: The pilot study of a screening protocol by neurosurgeon to avoid unnecessary transfers. J Clin Neurosci. 2020 Nov;81:246-251. doi: 10.1016/j.jocn.2020.09.050. Epub 2020 Oct 15.
- Individual participant dataSharing planned: Yes. Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
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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.
Richard Meyrat, MD principal investigator
The Methodist Hospital Research Institute
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 Traumatic Intracranial Subarachnoid Hemorrhage, run by Methodist Health System at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colette Ngo Ndjom, MS (214) 947-1289 ext. 71289, MHSIRB@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the historical rate of appropriate and inappropriate Methodist interfacility transfers for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleed. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136078, which also lists 1 linked publication.
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 18 Nov 2023.