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Chronic Subdural HematomaTOSCANNCT01624545

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

A study testing cranial CT scan in people with Chronic Subdural Hematoma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Subdural Hematoma
What is being tested?
cranial CT scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
1 siteSwitzerland
Study dates
1 Jun 2012to 6 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Neurosurgery

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

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

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.

Read the detailed description

Background

Chronic subdural hematoma (CSH) is one of the most common intracranial bleedings in patients over 60 years of age and a frequently found neurosurgical entity. Age related brain atrophy leads to enlargement of the subarachnoid space, a space limited by the dura mater and the arachnoid membrane. Blood vessels that occupy this space are being stretched and may rupture after a minor head trauma. Although the resulting bleeding itself is often without noticeable consequence for the patient, the anatomical outcome may be serious as it enlarges the subdural space. The formation of new leaky capillary-like vessels and/or volume enhancing osmotic gradients lead to the enlargement of the subdural hematoma over weeks, filling the intracranial space and compressing the brain. Headaches, gait disturbances, language problems, hemiparesis and decreased consciousness are among the many presenting symptoms and tend to develop over days or weeks.

Computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head typically reveals the blood accumulation in the subdural space. Standard treatment includes the evacuation of the subdural blood through burr holes (see below) under either local or general anesthesia. In cases when a hematoma clot cannot be evacuated through burr holes a small craniotomy is performed. CSH is feared for its high recurrence rate (between 9 and 27%) that mostly occurs within 3 months of the initial operation.

The optimal follow-up course for operated patients remains controversial. Due to the high rate of recurrences, one strategy is to perform serial CT scans in order to identify recurrent hematomas early. The radiologic evidence of a recurrent or significant persistent hematoma often leads to reoperation. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of persistent or new neurologic deficits. Advocators of this strategy argue that 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.

However, even when neuroimaging is done routinely, no correlation has been observed between the radiologic evidence of a hematoma remnant and the reoperation rate. This observation has been reported by Mori and Maeda in a retrospective analysis of 500 patients. Some persistent hematoma is almost always seen after the surgical intervention and there seems to be a correlation between the re-expansion rate of the brain and the likelihood of hematoma recurrence. However, the correlation is weak and of little practical value for patient treatment. The high incidence of hematoma remnants in post-op imaging complicates the indication for re-operation of a recurrent CSH solely by imaging criteria. Since the presence and the amount of remnant hematoma after the operation is a poor predictor of future recurrent hematoma some clinicians refrain from postoperative CT scans and rely solely on neurological assessments. If patients become symptomatic, serial CT scans are performed and surgery is scheduled in cases of persistent, enlarging or new hematoma. The discrepancy in follow-up strategy reflects our current incomplete understanding of the pathophysiology of CSH and its recurrence.

The aim of the current study is to evaluate the role of CT scanning in the postoperative treatment course after neurosurgical evacuation of CSH in a prospective, randomized controlled trial.

Objective

The hypothesis of interest to test in this trial is that a follow-up protocol without any CT scan is not inferior to a follow-up protocol with serial CT scans after neurosurgical evacuation of CSH as assessed with the modified Rankin scale at 6 months. Additional hypotheses of interest are that the size/volume/features of the hematoma rest/remnant in an early (<72 hours) CT scan after neurosurgical evacuation is not correlated to the neurological status of the patient and that the size/volume/features of the hematoma rest/remnant on post-op CT scans is not predictive for reoperation.

Methods

Patients will be screened and included into this study within 48 hours after surgery for a chronic subdural hematoma (burr hole trepanation and insertion of drainage). Study patients are randomized (1:1) on day 2 after surgery into CT-Scan arm (group A) or Clinical arm (group B). A CT scan is scheduled for patients of group A on day 2 and 30 after surgery. Patients of both study groups (A and B) will receive a neurological follow-up examination at day 2, 30 days and 6 months after surgery. Regardless of randomization all patients will receive CT scanning if judged necessary on clinical grounds at any time.

Being tested
cranial CT scan
Keywords
chronic subdural hematoma, burr hole trepanation, radiologic follow-up, outcome, recurrence
Medical subject headings
Hematoma, Subdural, Chronic, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cranial CT scanOther

    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.

Study groups in NCT01624545
Study groupRoleWhat they receive
1Active comparatorPatients 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.
Receives: Other: cranial CT scan
2No interventionPatients in this study arm will undergo neurological evaluation on day 2 and day 30 without follow-up CT scan.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. modified Rankin Scale

    Measured: 6 months

Secondary outcomes (6)
  1. Rate of reoperation

    Measured: 6 months

  2. Mini Mental Status

    Measured: 6 months

  3. NIHSS

    Measured: 6 months

  4. QLQ-C30

    Measured: 6 months

  5. Total length of hospitalisation

    Measured: 6 months

  6. Influence of the size and radiological features of the hematoma on rate of recurrence

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2012 (estimated)
  2. Study start1 Jun 2012
  3. Primary completion6 Feb 2017
  4. Study completion6 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624545
Sponsor's protocol ID
218/10
Other IDs
2179
Acronym
TOSCAN
Status last verified
Feb 2017
First submitted
18 Jun 2012
Last updated
13 Feb 2017
Results posted
No
Data monitoring committee
Yes

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. doi: 10.2176/nmc.41.371.

    PubMed 11561347
  • 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.

    PubMed 19008766
  • Forster MT, Mathe 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.

    PubMed 20580997
  • 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. doi: 10.1227/01.NEU.0000298908.94129.67.

    PubMed 17986941
  • 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. doi: 10.2176/nmc.41.382.

    PubMed 11561348
  • 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.

    PubMed 19782872
  • 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. doi: 10.3904/kjim.1991.6.1.33.

    PubMed 1742254

Questions about this trial

What is this clinical trial studying?

A study testing cranial CT scan in people with Chronic Subdural Hematoma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01624545, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.

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