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The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study

NCT01785797 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2013-02-07

No results posted yet for this study

Summary

This is a prospective randomised-controlled multi-centre trial based in Hong Kong to determine whether temporary subdural drain placement after burr hole evacuation of a chronic subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole operative drainage will be randomly allocated into one of two groups: (1) for intra-operative subdural drain placement (intervention group) or (2) not for drain placement (control group). Using web-based software block randomisation with an allocation ratio of 1:1 will be conducted. Instructions to use or not to use a drain will be contained in a sealed envelopes labelled with sequential study numbers.

Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the haematoma the patient's condition is unsafe for drain placement, the subject will be excluded from the study. Otherwise, randomisation will be performed at this juncture by the opening of the sealed envelop. The procedure involves placing a prefabricated silicon drain into the subdural space according to a standard protocol and will be removed on the second post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain placement is unsafe will be excluded from the study. Drainage is undertaken passively by hanging the collection bag at the bedside in a dependent position. In addition to general demographic, clinical and radiological presentation data, potential risk factors for recurrence will be documented. Serial computed tomography brain scans will be arranged (before discharge, at four weeks and six months) and the occurence of significant subdural haematoma recurrence requiring repeat operative drainage at six months will be recorded. Other outcome measures to be determined at regular time intervals for a total follow-up period of six months (upon discharge, at four weeks and six months) include: functional performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added neurological deficit, death and other surgery-related complications. All outcomes will be documented by the trial investigators or by the responsible clinician. The data obtained will be analysed according to the principle of intention to treat.

Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control), the additional placement of a subdural drain after evacuation (intervention) will reduce the risk of recurrence requiring repeat surgery.

Conditions

  • Chronic Subdural Hematoma
  • Subdural Drain

Interventions

DEVICE

Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma

Sponsors & Collaborators

  • Kwong Wah Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01785797 on ClinicalTrials.gov