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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01624545
First received: June 18, 2012
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Chronic Subdural Hematoma
Other: cranial CT scan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation - a Prospective, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • modified Rankin Scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of reoperation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Mini Mental Status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • NIHSS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • QLQ-C30 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total length of hospitalisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Influence of the size and radiological features of the hematoma on rate of recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30.
Other: cranial CT scan
Patients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30.
No Intervention: 2
Patients in this study arm will undergo neurological evaluation on day 2 and day 30 without follow-up CT scan.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours
  • Age 18 years or older
  • Written informed consent from the patient to participate in the study

Exclusion Criteria

  • Moribund state of health prohibiting surgery
  • Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
  • Recurrent hematoma if the first surgery was performed before study start
  • CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa
  • Pregnancy
  • Patient with Metastatic Disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624545

Contacts
Contact: Philippe E Schucht, MD +41 31632111 philippe.schucht@insel.ch

Locations
Switzerland
Department of Neurosurgery Recruiting
Bern, Switzerland, 3010
Contact: Nicole Söll, CDM    +41316323164    nicole.soell@insel.ch   
Contact: Philippe E Schucht, MD    +41316322409    philippe.schucht@insel.ch   
Principal Investigator: Philippe E Schucht         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Philippe E Schucht, MD Inselspital Bern, University Bern
  More Information

Publications:

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01624545     History of Changes
Other Study ID Numbers: 218/10, 2179
Study First Received: June 18, 2012
Last Updated: September 23, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
chronic subdural hematoma
burr hole trepanation
radiologic follow-up
outcome
recurrence

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Hemorrhage
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014