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

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ClinicalTrials.gov Identifier: NCT01624545

Recruitment Status : Completed

First Posted : June 20, 2012

Last Update Posted : February 13, 2017

Sponsor:

Information provided by (Responsible Party):

University Hospital Inselspital, Berne

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Chronic Subdural Hematoma	Other: cranial CT scan	Not Applicable

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	368 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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
Actual Study Start Date :	June 1, 2012
Actual Primary Completion Date :	February 6, 2017
Actual Study Completion Date :	February 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans Nuclear Scans

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

modified Rankin Scale [ Time Frame: 6 months ]

Secondary Outcome Measures :

Rate of reoperation [ Time Frame: 6 months ]
Mini Mental Status [ Time Frame: 6 months ]
NIHSS [ Time Frame: 6 months ]
QLQ-C30 [ Time Frame: 6 months ]
Total length of hospitalisation [ Time Frame: 6 months ]
Influence of the size and radiological features of the hematoma on rate of recurrence [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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 and a high possibility to pass away in the next 6 month

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624545

Locations


Switzerland
Department of Neurosurgery
Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators


Principal Investigator:	Philippe E Schucht, MD	Inselspital Bern, University Bern

More Information

Publications:

Mori K, Maeda M. Surgical treatment of chronic subdural hematoma in 500 consecutive cases: clinical characteristics, surgical outcome, complications, and recurrence rate. Neurol Med Chir (Tokyo). 2001 Aug;41(8):371-81.

Torihashi K, Sadamasa N, Yoshida K, Narumi O, Chin M, Yamagata S. Independent predictors for recurrence of chronic subdural hematoma: a review of 343 consecutive surgical cases. Neurosurgery. 2008 Dec;63(6):1125-9; discussion 1129. doi: 10.1227/01.NEU.0000335782.60059.17.

Forster MT, Mathé AK, Senft C, Scharrer I, Seifert V, Gerlach R. The influence of preoperative anticoagulation on outcome and quality of life after surgical treatment of chronic subdural hematoma. J Clin Neurosci. 2010 Aug;17(8):975-9. doi: 10.1016/j.jocn.2009.11.023. Epub 2010 May 23.

Abouzari M, Rashidi A, Rezaii J, Esfandiari K, Asadollahi M, Aleali H, Abdollahzadeh M. The role of postoperative patient posture in the recurrence of traumatic chronic subdural hematoma after burr-hole surgery. Neurosurgery. 2007 Oct;61(4):794-7; discussion 797.

Oishi M, Toyama M, Tamatani S, Kitazawa T, Saito M. Clinical factors of recurrent chronic subdural hematoma. Neurol Med Chir (Tokyo). 2001 Aug;41(8):382-6.

Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.

Lee HY, Ju YM, Lee MH, Lee SJ, Chang WH, Imm CW. A case of post-traumatic coronary occlusion. Korean J Intern Med. 1991 Jan;6(1):33-7. Review.


Responsible Party:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT01624545 History of Changes
Other Study ID Numbers:	218/10 2179
First Posted:	June 20, 2012 Key Record Dates
Last Update Posted:	February 13, 2017
Last Verified:	February 2017

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 Hemorrhage Pathologic Processes Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Cerebrovascular Disorders	Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Vascular Diseases Cardiovascular Diseases Wounds and Injuries

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