| CTRI Number |
CTRI/2024/04/065004 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see which type of surgery on the skull is better for brain swelling after head injury |
|
Scientific Title of Study
|
Decompressive Craniectomy versus Hinge
Craniotomy for Intracranial hypertension in
Traumatic Brain Injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhaval Shukla |
| Designation |
Professor, Neurosurgery |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
II Floor, Neuroscience Faculty Block,
Hospital Campus,
NIMHANS, Hosur Road, Dharmaram
Bangalore
KARNATAKA
560029
India |
| Phone |
9898073843 |
| Fax |
|
| Email |
neurodhaval@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhaval Shukla |
| Designation |
Professor, Neurosurgery |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
II Floor, Neuroscience Faculty Block,
Hospital Campus,
NIMHANS, Hosur Road, Dharmaram
KARNATAKA
560029
India |
| Phone |
9898073843 |
| Fax |
|
| Email |
neurodhaval@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhaval Shukla |
| Designation |
Professor, Neurosurgery |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
II Floor, Neuroscience Faculty Block,
Hospital Campus,
NIMHANS, Hosur Road, Dharmaram
KARNATAKA
560029
India |
| Phone |
9898073843 |
| Fax |
|
| Email |
neurodhaval@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Health and Care Research (NIHR) UK |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
II Floor, Neuroscience Faculty Block,
Hospital Campus,
NIMHANS, Hosur Road, Dharmaram P.O,
Bengaluru 560029 Karnataka |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute for Health and Care Research |
National Institute for Health and Care Research (NIHR)
UK |
|
|
Countries of Recruitment
|
Pakistan
Brazil
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhaval Shukla |
NIMHANS, Bangalore |
Emergency care block, trauma centre, ground floor,NIMHANS
Bangalore
KARNATAKA |
9898073843
neurodhaval@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics committe (Basic and Neurosciences division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S061||Traumatic cerebral edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Decompressive craniectomy |
The large craniotomy bone flap (12 cm or more) is not kept back in the skull to allow the swollen brain to expand, and this helps reduce the intracranial pressure. The bone flap will be kept in an abdominal pouch or will be stored in a deep freezer so that it can be replaced at a second surgery when the patients brain swelling has come down. This intervention is a single-time procedure usually done within one week of admission, and the surgery should last about four hours. |
| Intervention |
Hinge craniotomy |
After doing a large craniotomy (diameter greater than 12 cm), the bone flap will be split into multiple pieces (three, usually), and the pieces will then be joined together with sutures or metal plates in such a way that the pieces can open outwards to relieve the pressure from the swollen brain. The split pieces will settle back to the near-normal, previous shape of the skull when the pressure in the skull has reduced because of the way it is joined loosely. The joining mechanism prevents the sinking of the bone into the skull when the pressure has become normal. This intervention is a single-time procedure usually done within one week of admission, and the surgery should last about four hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Male |
| Details |
Closed head injury patients in whom brain swelling is indicative of raised intracranial pressure that is no longer controlled by medical management |
|
| ExclusionCriteria |
| Details |
Unsurvivable injury
Comoborbidities that prevent surgical treatment
Previous history of decompressive craniectomy (DC) or cranioplasty where further DC or hinge craniotomy cannot be done.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extended Glasgow Outcome Scale (GOSE) |
12 months from injury |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in intracranial pressure |
24 hours after the intervention (surgery) [if an ICP monitoring was done] |
| Extended Glasgow Outcome Scale (GOSE) |
One, three, and six months |
| Wound complications |
14 days of intervention |
| Postoperative hydrocephalus |
12 months after injury |
| Timing of cranioplasty (in the DC group) |
12 months after injury |
| Method of storage of the bone flap in the DC group |
12 months of injury |
| Duration of hospitalisation |
12 months of injury |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="250"
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 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial aims to find which of the two surgical procedures (decompressive craniectomy, where a large bone flap is removed from the skull, versus hinge craniotomy, where the replaced bone flap is split in a way to allow expansion to accommodate the swollen brain) is superior in the management of diffuse cerebral edema causing raised intracranial pressure in closed traumatic brain injury. |