NCT01624545: TOSCAN

To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation

Completed NA Last updated 13 February 2017

What this trial tests

NA trial testing cranial CT scan in Chronic Subdural Hematoma in 368 participants. Completed in 6 February 2017.

Timeline

1 June 2012

Primary endpoint
6 February 2017

6 February 2017

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	368
Start date	1 June 2012
Primary completion	6 February 2017
Estimated completion	6 February 2017
Sites	1 location across Switzerland

Drugs / interventions tested

• cranial CT scan

Conditions studied

• Chronic Subdural Hematoma — all drugs for Chronic Subdural Hematoma →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Chronic Subdural Hematoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.

The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.

The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. European Stroke Organisation Conference: Late Breaking Abstracts
   · 2018