Randomized controlled non-inferiority trial of subperiosteal versus subdural drain placement after burr holes craniostomy surgery for chronic subdural hematoma to reduce recurrence risk and improve neurological outcome.
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To find if the recurrence rate of CSDH (requiring re-surgery) when treated with subperiosteal drain is non-inferior to subdural drain placement when evaluated at the end of three months (12-14 weeks).
Overview
Brief Summary
Chronic subdural hematoma (CSDH) is a relatively common intracranial hematoma that occurs mainly in older adults and it is characterized by the slow accumulation of blood between
the cerebral cortex and dura mater. Clinical manifestations of CSDH vary depending on
the size of the hematoma and the extent to which it compresses different parts of the brain,
and common features include headache, limb weakness, cognitive deterioration, and epilepsy.
At present, the most common treatment strategy for CSDH is to wash out the hematoma using one or two burr holes craniostomy and then placing a drain to ensure that the blood does not re-aggregate in the space left following the removal of the hematoma.
The traditional method of placing a drain is into the subdural space through the burr hole craniostomy, which might increase the risk of brain parenchymal injury due to manipulation of the drain on the surface of the brain either during its insertion or when one removes it. There is also the risk of misplacement of the drain into the parenchyma of the brain.
Subperiosteal drain placement (otherwise called sub-galeal drain) could be a better option as the drain is placed over the burr hole craniostomy. Since the burr hole is not closed, any fluid, including blood, can seep out of the hole into the drain placed above it.
The research question is as follows:
Is the subperiosteal location of the drain non-inferior to subdural placement regarding recurrence in CSDH patients?
Aims and objectives
To find if the recurrence rate of CSDH (requiring re-surgery) when treated with subperiosteal drain is non-inferior to subdural drain placement when evaluated at three months.
The co-primary outcome will be the neurological status measured by the modified Rankin scale (mRS), at three months.
(An ordinal shift method will be used to analyse the mRS outcome (Johns et al. 2023))
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults (18 years to 110 years) Symptomatic with CSDH seen on CT or MRI Asymptomatic CSDH patients, but imaging shows a large CSDH or a big midline shift (1 cm or more) that the clinical team feels that it would be risky to manage nonoperatively.
- •Patients on antiplatelets or anticoagulants are not a contraindication as long as they are fit for burr hole craniostomy, as per the judgement of the treating team.
Exclusion Criteria
- •Moribund patient (GCS E1M1VT) or GCS E1M2Vt with CT findings of extensive herniation-induced infarcts where survival beyond 24 hours is not expected with or without treatment A recurrent CSDH A pre-diagnosis mRS of 2 or more (2 is a slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance) Asymptomatic, thin CSDH where surgery is not required.
- •Mini-craniotomy Iatrogenic CSDH like that caused by a ventriculoperitoneal shunt.
Outcomes
Primary Outcomes
To find if the recurrence rate of CSDH (requiring re-surgery) when treated with subperiosteal drain is non-inferior to subdural drain placement when evaluated at the end of three months (12-14 weeks).
Time Frame: To find if the recurrence rate of CSDH (requiring re-surgery) when treated with subperiosteal drain is non-inferior to subdural drain placement when evaluated at the end of three months (12-14 weeks). | The co-primary outcome will be the neurological status measured by the modified Rankin scale (mRS), at the end of three months (12-14 weeks).
The co-primary outcome will be the neurological status measured by the modified Rankin scale (mRS), at the end of three months (12-14 weeks).
Time Frame: To find if the recurrence rate of CSDH (requiring re-surgery) when treated with subperiosteal drain is non-inferior to subdural drain placement when evaluated at the end of three months (12-14 weeks). | The co-primary outcome will be the neurological status measured by the modified Rankin scale (mRS), at the end of three months (12-14 weeks).
Secondary Outcomes
- Is the rate of complications (composite outcome of a new bleed requiring observation or reoperation, infection, and a large pneumocephalus requiring repeated scans or observation or intervention) lesser when a sub-periosteal drain is placed compared to a subdural location?
- To find if the recurrence rate of CSDH when treated with a subperiosteal drain is lower than that of the subdural drain placement at three months. (superiority)(Three months from randomisation)
- The modified Rankin Scale(Six months after randomization)
- Recurrence of the chronic subdural hematoma(Six months from randomisation)
- The outcome (functional independence) measured by mRS at three months and six months dichotomised to good outcome (0 and 1 mRS) and bad outcome (2 or above)(Three and six months)
Investigators
Gopalakrishnan MS
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)