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

NCT01624545 | Completed DMC

• 2 other identifiers: 218/102179
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

chronic subdural hematoma; burr hole trepanation; radiologic follow-up; outcome; recurrence

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale

  6 months

Secondary Outcomes (6)

• Rate of reoperation

  6 months

• Mini Mental Status

  6 months

• NIHSS

  6 months

• QLQ-C30

  6 months

• Total length of hospitalisation

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

NO INTERVENTION

Patients in this study arm will undergo neurological evaluation on day 2 and day 30 without follow-up CT scan.

Interventions

cranial CT scan OTHER

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Neurosurgery

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 11561347 BACKGROUND

• 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.

  PMID: 19008766 BACKGROUND

• 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.

  PMID: 20580997 BACKGROUND

• 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.

  PMID: 17986941 BACKGROUND

• 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.

  PMID: 11561348 BACKGROUND

• 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.

  PMID: 19782872 BACKGROUND

• 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.

  PMID: 1742254 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Philippe E Schucht, MD

  Inselspital Bern, University Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: June 1, 2012
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

CH (1)