The "Concussion or Brain Bleed" Trial

Not Applicable

• Conditions: Head Injury

• Registration Number: NCT04002505
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-27
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of CT Scans	6 months	Number of CT scans performed when using the Concussion and Brain Bleed app

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States