Selective CT for Traumatic Brain Injury

(Can-SCAHn Trial)

Recruiting at 8 trial locations

Overseen By Natasha Clayton, CRA, RA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Kerstin de Wit

Must be taking: Anticoagulants

Disqualifiers: Penetrating head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines when head scans (CTs) are necessary for individuals on blood thinners who have sustained a head injury. The goal is to determine a safe method for deciding if a scan can be skipped without overlooking a serious brain injury. The trial also evaluates the effectiveness of current guidelines for head injuries in these patients. Suitable participants have recently experienced a head injury, are on blood thinners, and are visiting the emergency room for a head CT (Selective CT). As an unphased trial, this study allows participants to contribute to important research that could enhance decision-making in emergency care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study involves patients who are already using anticoagulant medications, it seems likely that you will continue taking them.

What prior data suggests that this clinical decision rule is safe for head-injured ED patients on anticoagulant medications?

Research has shown that using CT scans only when necessary is generally safe and effective for some patients. For example, studies have found that in certain situations, selectively using CT scans can be safe and practical. Researchers have studied this method in different patient groups, including those with specific injuries or conditions.

However, detailed information from studies that randomly compare selective CT scans to routine CT scans for injuries is limited. Most evidence comes from observational studies, which might not provide a complete picture.

Overall, if a treatment like selective CT is being tested in a trial, the existing evidence is strong enough to consider it safe for further testing. Always consult a healthcare provider to understand more about the details and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Selective CT for anticoagulated head injured patients because it aims to refine and improve the way we decide which patients need a CT scan after a head injury. Unlike the standard approach, which often involves scanning all patients on blood thinners regardless of injury severity, Selective CT uses specific criteria to identify those who truly need imaging. This could reduce unnecessary radiation exposure and healthcare costs while still ensuring patient safety. The trial seeks to find out if this more targeted method offers the same, if not better, outcomes compared to the usual practice.

What evidence suggests that this clinical decision rule is effective for excluding traumatic brain injury in head-injured ED patients on anticoagulants?

Research has shown that targeted CT scans can be as effective as whole-body scans for some trauma patients. Specifically, studies have found that in stable trauma patients, targeted CT scans yield similar results while reducing radiation exposure. For head and facial injuries, targeted CT scans match the effectiveness of full-body scans. This suggests that for patients on blood thinners with head injuries, targeted CT scans might safely detect brain injuries without additional radiation. Overall, targeted CT scans offer a focused approach that could be both effective and safer for these patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Kerstin de Wit, MD

Principal Investigator

Queens University

Are You a Good Fit for This Trial?

Inclusion Criteria

Age ≥16 years

Presents to the emergency department after a head injury

Patient has a head CT in the emergency department

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Emergency physicians record clinical predictors for traumatic brain injury and perform head CT scans

1 day

1 visit (in-person)

Follow-up

Participants are monitored for delayed clinically important traumatic brain injury

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Selective CT

Who Is Running the Clinical Trial?

Dr. Kerstin de Wit

Lead Sponsor

Trials

3

Recruited

5,700+

Kerstin de Wit

Lead Sponsor

Trials

1

Recruited

4,000+

Dr. Kerstin de Wit

Lead Sponsor

Trials

4

Recruited

9,700+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8563841/

Outcome of selective CT vs. pan-CT scan in elderly trauma ... Many studies showed the effectiveness of whole body CT over selective CT scan., Salim and colleagues showed that whole-body CT resulted in a change of ...

2. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/whole-body-computed-tomography-versus-selective-radiological-imaging-strategy-in-trauma-patients-3975/

Whole Body Computed Tomography versus Selective ... However, current literature offers limited evidence that immediate total-body CT improves clinical outcomes over conventional imaging with selective CT.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480421002390

Selective Computed Tomography (CT) Imaging is Superior ... Selective CT imaging in hemodynamically stable blunt pediatric trauma patients was associated with reduced radiation exposure and similar outcomes

4. sjtrem.biomedcentral.com sjtrem.biomedcentral.com/articles/10.1186/s13049-014-0054-2

Comparison of whole-body computed tomography vs selective ... The present meta-analysis suggests that the application of whole-body CT significantly reduces the mortality rate of MTPs and markedly reduces the time spent ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5325908/

Pan vs. Selective Computed Tomography Scans in ... It seems that doing selective CT scan yields results similar to pan CT in detection of head and face, neck and abdomen and hip injuries in multiple trauma ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25185470/

conclusions on safety, efficacy, and the role of selective CT ... Conclusions: The NOM of appropriately selected patients with AGSW with selective use of CT scanning is feasible, safe, and effective, but largely based on ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1008127521000833

Outcome of selective CT vs. pan-CT scan in elderly trauma ... The Trauma Audit Research Network database was reviewed to identify eligible patients (≥65 years) over a one-year period, from January 2018 to January 2019.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6464744/

Selective computed tomography (CT) versus routine ... We found no RCTs of routine versus selective thoracoabdominal CT in patients with blunt high‐energy trauma. Based on the lack of evidence from RCTs, it is not ...

9. emdocs.net emdocs.net/reign-pan-scan-whole-body-ct-vs-selective-imaging-trauma/

The Reign of the “Pan-Scan”: Whole Body CT vs. Selective ... This post will evaluate the literature surrounding whole body CT in trauma, specifically whether mortality is improved with its use.

10. annemergmed.com annemergmed.com/article/S0196-0644(11)00611-1/fulltext

Selective Use of Computed Tomography Compared With ... This article presents data for all 701 patients in the completed study and examines physicians' beliefs about the importance of missed injuries ...