The "Concussion or Brain Bleed" Trial

Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04002505

Enrollment

370

Registered

2019-06-28

Start date

2019-06-27

Completion date

2030-12-01

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injury

Brief 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.

Interventions

OTHERConcussion 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Patients who are pregnant * Non-English speaking * In police custody * Undergoing psychiatric evaluation * Found to have drug or alcohol intoxication

Design outcomes

Primary

Measure	Time frame	Description
Rate of CT Scans	6 months	Number of CT scans performed when using the Concussion and Brain Bleed app

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNeha Raukar, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026