Selective CT for Anticoagulated Head Injured Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorDr. Kerstin de Wit
About this trial
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. 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. Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study enrolls a anticoagulated emergency department patients presenting within 48 hours of a blunt head injury.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Index emergency department presentationSecondary outcomes
1
Delayed 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.
Time frame
Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Kerstin de Wit
Lead sponsor
Queen's University
Sponsor institution
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov