A Preliminary Randomized Controlled Trial comparing the incidence of 48-hour Revisit and Post-Concussion Syndrome between Early Emergency Department Discharge versus Observation in Patients with Negative CT scan Mild Traumatic Brain Injury

Phase 3

Completed

• Conditions: A preliminary study comparison of early discharge and ED observation in negative CT scan mild traumatic brain injury patients in ED; mild traumatic brain injury, early discharge

• Registration Number: TCTR20211018008
• Lead Sponsor: /A

Brief Summary

Patients with mild TBI, normal initial CT scans, and no other injuries or neurological abnormalities can safely be discharged without inpatient or outpatient observation. This may imply that the recommendation to discharge immediately after the CT results are negative has no difference in clinical outcome and a low risk of delayed bleeding.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-18
• Study Completion: 2023-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. mild traumatic brain injury, moderate to high risk
2. negative result in CT scan

Exclusion Criteria

1. Glasgow Coma Scale below 12
2. penetrating head trauma
3. onset of head injury more than 24 hours
4. multisystem trauma that require admission or other observation
5. hematologic disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified