Head InjuryNCT04002505
The "Concussion or Brain Bleed" Trial
A study testing Concussion and Brain Bleed App (CBB) in people with Head Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Head Injury
- What is being tested?
- Concussion and Brain Bleed App (CBB)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to Dec 2030
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Present to the Emergency Department with a blunt head injury within the past 24 hours
- Determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider.
Who cannot join
- Patients who are pregnant
- Non-English speaking
- In police custody
- Undergoing psychiatric evaluation
- Found to have drug or alcohol intoxication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial
Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.
- Conditions
- Head Injury
- Being tested
- Concussion and Brain Bleed App (CBB)
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concussion and Brain Bleed App (CBB)Other
Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans
| Study group | Role | What they receive |
|---|---|---|
| Head Injury Subject | Experimental | Subjects that present to the Emergency Department with a blunt head injury within the past 24 hours, determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider will use the shared decision making tool Concussion and Brain Bleed app (CBC) with their clinician Receives: Other: Concussion and Brain Bleed App (CBB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CT Scans
Number of CT scans performed when using the Concussion and Brain Bleed app
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start27 Jun 2019
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neha P. Raukar, Mayo Clinic
- Investigators
- Neha Raukar, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002505
- Sponsor's protocol ID
- 19-000224
- Status last verified
- May 2026
- First submitted
- 27 Jun 2019
- Last updated
- 29 May 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial
- ClinicalTrials.gov ID
- NCT04002505
- Acronym / sponsor ID
- 19-000224
- Conditions
- Head Injury
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Jun 2019 (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.
Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head Injury Subject | Experimental | Other: Concussion and Brain Bleed App (CBB)Subjects that present to the Emergency Department with a blunt head injury within the past 24 hours, determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider will use the shared decision making tool Concussion and Brain Bleed app (CBC) with their clinician |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- Present to the Emergency Department with a blunt head injury within the past 24 hours
- Determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider.
Key exclusion criteria (5 listed)
- Patients who are pregnant
- Non-English speaking
- In police custody
- Undergoing psychiatric evaluation
- Found to have drug or alcohol intoxication
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 |
|---|---|---|
| Concussion and Brain Bleed App (CBB)Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans | Other | Head Injury Subject |
Primary outcome
Rate of CT Scans
Time frame: 6 months
Number of CT scans performed when using the Concussion and Brain Bleed app
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 29 May 2026.
- Mayo Clinic Clinical Trials (open in google chrome)Link provided by the sponsor.
- 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.
Neha Raukar, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concussion and Brain Bleed App (CBB) in people with Head Injury, run by Mayo Clinic 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 5 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: enrolling by invitation, as of the sponsor's last update on 29 May 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 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?
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?
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?
Rate of CT Scans (time frame: 6 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 29 May 2026.