To investigate whether controlled decompression therapy reduces the incidence of comorbidities and enhances recovery in traumatic brain injury patients
Design
A two arm parallel group randomised trial with blinded postoperative care and outcome assessment on a total sample of 52 participants.
Settings and conduct
The study was conducted at the neurosurgery unit, Afridi Medical Complex. Patients with elevated ICP underwent therapeutic hypothermia for 7–10 days. ICP was regularly checked with an ICP sensor, which was normally taken out around a week following surgery. Every two hours, the ICP and vital signs were monitored and noted. If the patients were stable at 1, 24, and 72 hours following the procedure, the cranial CT data were routinely evaluated. The outcome assessor during the process will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with TBI between the ages of 18 and 75 who gave informed permission and had a Glasgow Coma Scale (GCS) score between 3 and 8 at admission were eligible.
Exclusion criteria: Exclusion criteria included the following: initial need for bilateral craniotomy; preoperative GCS score of 3 with no improvement after treatment in the emergency room; presentation without attenuated respiration
Intervention groups
Experimental group: Standard surgical techniques were used to achieve a rapid craniotomy. The fast removal of the hematoma and brain contusion tissue was the main objective of the procedure.
Control Group: The best option was a brain tissue monitor, followed by a ventricular intracranial pressure monitor. The dura was completely opened, and the hematoma or brain contusion tissue was then removed when the ICP was less than 10 mmHg and there were no visible evidence of bulging brain tissue.
Main outcome variables
The Extended Glasgow Outcome Scale (GOSE)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230907059376N1
Registration date:2023-09-13, 1402/06/22
Registration timing:retrospective
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Sarmad Khattak
Name of organization / entity
Rehman Medical Institute, Peshawar
Country
Pakistan
Phone
+92 91 5838666
Email address
sarmadkhattak007@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-13, 1401/05/22
Expected recruitment end date
2023-08-13, 1402/05/22
Actual recruitment start date
2022-09-21, 1401/06/30
Actual recruitment end date
2023-08-13, 1402/05/22
Trial completion date
2023-08-27, 1402/06/05
Scientific title
Controlled decompression effects in the patients with severe TBI: A Randomized Control Trial
Public title
Controlled decompression effects in the patients with severe TBI: A Randomized Control Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with TBI between the ages of 18 and 75
Patients who gave informed permission
Glasgow Coma Scale (GCS) score between 3 and 8 at admission
Exclusion criteria:
Initial need for bilateral craniotomy
Preoperative GCS score of 3 with no improvement after treatment in the emergency room
Presentation without attenuated respiration and blood pressure
Combination of anoxia and hypotension with brain swelling caused by anoxia or hypotension and minor intracranial bleeding after injury
Coagulation disorder or a history of aspirin intake and multiorgan malfunction
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In our trial, randomization was conducted using a computer-generated random sequence that allocated participants into one of two groups: controlled decompression or fast decompression, following Traumatic Brain Injury (TBI) prior to surgery. This randomization process ensured that each participant had an equal and unbiased chance of being assigned to either group, minimizing potential selection bias and allowing for a more reliable assessment of the treatment outcomes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Afridi Medical Complex ethical committee
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25150
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
AMI/NS/10
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Global disability and recovery after traumatic brain injury
Timepoint
Baseline and after 6 months
Method of measurement
Extended Glasgow Outcome Scale (GOSE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Standard surgical techniques were used to achieve a rapid craniotomy.The dura was entirely opened by a normal large craniotomy (12 to 15 cm), allowing the ICP to be quickly, totally, and uncontrollably discharged. ICP monitoring was given to each patient in this group. The intraoperative surgical approach did not take the ICP into account, and the rate of ICP decline was not managed during the procedure. The fast removal of the hematoma and brain contusion tissue was the main objective of the procedure.
Category
Treatment - Surgery
2
Description
Control group: The goal of controlled decompression was to guarantee that the ICP would gradually release over the whole treatment using a variety of techniques. ICP dropped at a rate of 10-15 mmHg per 10 minutes. Before the craniotomy, an ICP probe was implanted to get the initial ICP. The best option was a brain tissue monitor, followed by a ventricular intracranial pressure monitor. Cerebrospinal fluid (CSF) was gradually discharged until the ICP was > 40 mmHg if the initial ICP was greater than that value. Second, to pressurize the brain and prevent a sharp drop in ICP after the bone was removed, a craniotomy with a bone window (12 ×15 cm) was necessary. Third, a small incision no bigger than 5 mm, which is frequently the diameter of the aspirator head, was used to breach the dura. The ICP was steadily decreased while the hematoma and brain contusion tissue were carefully aspirated. The dura was completely opened, and the hematoma or brain contusion tissue was then removed when the ICP was less than 10 mmHg and there were no visible evidence of bulging brain tissue.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afridi Medical Complex, Peshawar
Full name of responsible person
Mehboob Khan
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25150
Phone
+92 91 5711751
Email
mehbob509@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Afridi Medical Complex, Peshawar
Full name of responsible person
Mahboob Khan
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25150
Phone
+92 91 5711751
Email
mehboob509@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Afridi Medical Complex, Peshawar
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Royal Preston Hospital, Preston UK
Full name of responsible person
Abdul Hameed Khan
Position
Junior Clinical Fellow
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Sharoe Green Ln, Fulwood, Preston PR2 9HT, UK
City
Preston
Province
Preston
Postal code
PR2 9HT
Phone
+44 1772 716565
Email
drhameedkhan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Afridi Medical Complex, Peshawar
Full name of responsible person
Mahboob Khan
Position
Consultant Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25150
Phone
+92 91 5711751
Email
mehboob509@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Afridi Medical Complex, Peshawar
Full name of responsible person
Mahboob Khan
Position
Consultant Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25150
Phone
+92 91 5711751
Email
mehboob509@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Controlled decompression effects in the patients with severe TBI:
A Randomised Control Trial
When the data will become available and for how long
Next year
To whom data/document is available
Neuro surgeon
Under which criteria data/document could be used
Through email
From where data/document is obtainable
Contacting Principal author through email
What processes are involved for a request to access data/document
Contact Principal author Dr Mhaboob through email.
Email of the author is: mehbob509@gmail.com