| CTRI Number |
CTRI/2024/10/075273 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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). |
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Scientific Title of Study
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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.
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopalakrishnan MS |
| Designation |
Professor, Neurosurgery |
| Affiliation |
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER) |
| Address |
Second floor,Room 4, Neurosurgery Department, Super Specialty Block (SSB), Gorimedu, JIPMER
Pondicherry
PONDICHERRY
605008
India |
| Phone |
09442587797 |
| Fax |
|
| Email |
gopalakrishnanms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopalakrishnan MS |
| Designation |
Professor, Neurosurgery |
| Affiliation |
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER) |
| Address |
Second floor,Room 4, Neurosurgery Department, Super Specialty Block (SSB), Gorimedu, JIPMER
PONDICHERRY
605008
India |
| Phone |
09442587797 |
| Fax |
|
| Email |
gopalakrishnanms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gopalakrishnan MS |
| Designation |
Professor, Neurosurgery |
| Affiliation |
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER) |
| Address |
Second floor,Room 4, Neurosurgery Department, Super Specialty Block (SSB), Gorimedu, JIPMER
PONDICHERRY
605008
India |
| Phone |
09442587797 |
| Fax |
|
| Email |
gopalakrishnanms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER) Dhanvanthari Nagar, Gorimedu, Pondicherry, 605006
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Primary Sponsor
|
| Name |
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER) |
| Address |
Dhanvanthari Nagar, Gorimedu, Pondicherry
|
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikash |
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER) |
EMSD block (Neurosurgery), ground floor, room 4001, JIPMER
Pondicherry
PONDICHERRY |
8285554761
vikash.yadav9419@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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. Usually, the subdural drain will be a silicone tube typically used to place the external ventricular drain (a pliable small white tube with perforations at the distal two cm or the perforated Jackson Pratt type drain (Romovac â„¢ or equivalent). A vacuum will not be applied for the sub-dural location. The catheter will be kept for a minimum time of 24 hours (usually removed within 24-36 hours).
|
| Comparator Agent |
Sub-periosteal placement of the drainage catheter |
After evacuating the sub dural hematoma, the surgeon will place a catheter over the burrholes on top of the skull. We will prefer to use the Jackson Pratt type drain catheter since a longer segment of such tubes has perforations, and that will allow us to place a single tube over both the burrholes. If such a tube is not available, alternatives could include silicone "EVD" catheters or a Foley catheter. The catheter will be kept for a minimum time of 24 hours (usually removed within 24-36 hours).
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
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| ExclusionCriteria |
| Details |
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
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Centralized |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
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).
|
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 Outcome
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| Outcome |
TimePoints |
| 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 |
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?
|
Within discharge from hospital (usually within seven days 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 |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gopalakrishnanms@gmail.com].
- For how long will this data be available start date provided 20-12-2026 and end date provided 20-12-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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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))
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