NCT05364749

Brief Summary

The goal is to derive and a clinical decision rule for safe exclusion of traumatic brain injury without neuroimaging in head-injured ED patients who take anticoagulant medications. The objectives are to:

  1. 1.Derive and externally validate a new highly sensitive and maximally specific clinical decision rule for the exclusion of traumatic brain injury in head-injured ED patients who take anticoagulant medications; and,
  2. 2.Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2022Sep 2027

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Expected
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

May 3, 2022

Last Update Submit

April 11, 2026

Conditions

Head InjuryTraumatic Brain InjuryBlunt Head InjuryIntracranial Hemorrhage, Traumatic

Outcome Measures

Primary Outcomes (1)

  • Clinically important traumatic brain injury

    Clinically important TBI is defined as the diagnosis of bleeding within the cranial vault, diffuse axonal injury or an isolated skull fracture, which also receives hospital intervention or causes death within 90 days of the traumatic brain injury diagnosis.

    Index emergency department presentation

Secondary Outcomes (1)

  • Delayed clinically important traumatic brain injury

    Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study enrolls a anticoagulated emergency department patients presenting within 48 hours of a blunt head injury.

You may qualify if:

  • Age ≥16 years
  • Presents to the emergency department after a head injury
  • Patient has a head CT in the emergency department
  • Is a current anticoagulant user

You may not qualify if:

  • Head injury occurred \>48 h before patient's arrival to the emergency department
  • Penetrating head injury
  • Previously enrolled
  • Patient resides outside of the hospital's catchment area
  • Patient was transferred from another emergency department following neuroimaging
  • Patient was not managed by the emergency or trauma physician in the emergency department
  • Leaves the emergency department prior to completion of their medical assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

NOT YET RECRUITING

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

NOT YET RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, N3T 6P9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

Sinai Health

Toronto, Ontario, M5G 1X5, Canada

NOT YET RECRUITING

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

NOT YET RECRUITING

CHU de Québec - Université Laval

Québec, Quebec, G1R 2J6, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, TraumaticIntracranial Hemorrhage, TraumaticHead Injuries, Closed

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesWounds, Nonpenetrating

Study Officials

  • Kerstin de Wit, MD

    Queens University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Clayton, CRA, RA

CONTACT

416-566-3590natasha.clayton@queensu.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 6, 2022

Study Start

February 1, 2022

Primary Completion

March 15, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(7)