A study to see which location of a drain tube (placed below the covering of the brain or over the bone) is better in terms of neurological outcome after surgery for the removal of a chronic subdural hematoma (bleeding in the brain).

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. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075273

Enrollment

100

Registered

2024-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G94- Other disorders of brain in diseases classified elsewhere

Interventions

Intervention1: Sub-dural placement of the drainage catheter: The subdural catheter (typically a silicone one) will be placed through the parietal burrhole in a subdural location over the brain. Usual

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	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). Timepoint: 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).	—

Measure

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). Timepoint: 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).

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Secondary

Measure	Time frame
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)Timepoint: Three months from randomisation;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? Timepoint: Within discharge from hospital (usually within seven days from randomisation);The modified Rankin ScaleTimepoint: Six months after randomization;Recurrence of the chronic subdural hematomaTimepoint: 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)Timepoint: Three and six months	—

Measure

Time frame

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)Timepoint: Three months from randomisation;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? Timepoint: Within discharge from hospital (usually within seven days from randomisation);The modified Rankin ScaleTimepoint: Six months after randomization;Recurrence of the chronic subdural hematomaTimepoint: 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)Timepoint: Three and six months

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Countries

India

Contacts

Public ContactGopalakrishnan MS

Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)

gopalakrishnanms@gmail.com09442587797

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026