To determine the importance of timing in craniotomy in spontaneous intracerebral haemorrhage
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. Sample size of the study was 70.
Settings and conduct
The study was conducted at Khyber Teaching Hospital. The outcome assessor in study was blinded. The group has been regularly followed up with imaging to see whether the treatment has worked or not.
Participants/Inclusion and exclusion criteria
For this study, the inclusion criteria were patients ranging from 18 to 70 who were diagnosed with spontaneous ICH and confirmed by neuroimaging to have a Glasgow Coma Scale (GCS) score of 5–18. Patients who have traumatic intracerebral bleeding, all the cases requiring surgical intervention, and every deep-seated bleeding, coagulopathy, pregnancy, or pre-existing neurological condition that could affect results were excluded from this study.
Intervention groups
A randomly assigned intervention group (medical management) was treated through regular medical care in line with set guidelines, without cutoff monitoring of vital signs and neurological status, as well as timely intervention for complications. The group has been regularly followed up with imaging to see whether the treatment has worked or not.
Main outcome variables
Functional independence measure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230907059376N4
Registration date:2024-02-14, 1402/11/25
Registration timing:retrospective
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
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
2022-01-21, 1400/11/01
Expected recruitment end date
2022-09-16, 1401/06/25
Actual recruitment start date
2022-02-03, 1400/11/14
Actual recruitment end date
2022-08-17, 1401/05/26
Trial completion date
2022-09-03, 1401/06/12
Scientific title
Importance of timing in craniotomy in Spontaneous intracereberal haemorrhage
Public title
Importance of timing in craniotomy in Spontaneous intracereberal haemorrhage: experience in tertiary care hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients age range from 18 to 70 years
Patients of both genders, i.e. male and female
Patients who were diagnosed with spontaneous ICH and confirmed by neuroimaging to have a Glasgow Coma Scale (GCS) score of 5-18
Exclusion criteria:
Patients who have traumatic intracerebral bleeding
All the cases requiring surgical intervention
Deep-seated bleeding, coagulopathy, pregnancy, or pre-existing neurological conditions that could affect results were excluded from this study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we implemented randomization to ensure unbiased allocation of participants to treatment groups. We employed block randomization, grouping participants based on specific criteria, and then randomly assigning them to treatment groups within each block. This method helps maintain balance across treatment groups and controls for potential confounding variables. Randomization was carried out at the individual level, ensuring each participant had an equal chance of being assigned to any treatment group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors were blinded to treatment assignments through the utilization of sealed envelopes containing group allocations, ensuring impartial evaluation of study outcomes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committe of khyber teaching hospital
Street address
University Rd, Rahat Abad, Peshawar, Khyber Pakhtunkhwa, Pakistan
City
Peshawar
Postal code
25000
Approval date
2022-01-12, 1400/10/22
Ethics committee reference number
kth/ns/2022/02
Health conditions studied
1
Description of health condition studied
Intracranial Haemorrhage
ICD-10 code
I62.9
ICD-10 code description
Nontraumatic intracranial hemorrhage, unspecified
Primary outcomes
1
Description
Functional Independance measure
Timepoint
The measurement was taken at baseline and after 90 days
Method of measurement
A modified Ranken scale was used to assess the functional independance measure
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This approach involved providing standard medical care without immediate surgical intervention. Specifically, patients received routine medical attention aimed at stabilizing their condition and managing symptoms. This included pharmacological interventions such as medications to control blood pressure, pain management, and other supportive measures. However, crucially, these patients did not undergo surgical procedures such as craniotomy for hematoma evacuation.Additionally, patients in the medical management group did not undergo continuous monitoring of vital signs and neurological status, nor was there a predefined cutoff point for initiating surgical intervention based on changes in these parameters. Instead, they were managed conservatively with medical therapy alone, with interventions for complications initiated as clinically indicated rather than preemptively.
Category
Treatment - Drugs
2
Description
Intervention group: Patients assigned to the early surgical intervention group received a more aggressive treatment approach involving prompt surgical intervention within 24 hours of symptom onset. This involved performing a craniotomy procedure aimed at evacuating the hematoma and achieving control of the bleeding source. The surgical intervention was conducted promptly to minimize the potential deleterious effects of the hematoma, such as increased intracranial pressure and compression of vital brain structures.Unlike the medical management group, patients in the early surgical intervention group underwent surgical procedures aimed at directly addressing the underlying pathology causing their symptoms. This proactive approach aimed to expedite hematoma evacuation and prevent further neurological deterioration associated with delayed surgical intervention.Following the surgical procedure, patients in both groups were regularly monitored and followed up with imaging studies to assess the efficacy of the treatment approach. This allowed clinicians to evaluate the resolution of the hematoma, assess for any complications related to the intervention, and track the overall clinical progress of the patients over time.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khyber Teaching Hospital, Peshawar
Full name of responsible person
Muhammad Idrees Khan
Street address
University Rd, Rahat Abad, Peshawar, Khyber Pakhtunkhwa, Pakistan
City
Peshawar
Postal code
25000
Phone
+92 91 9224400
Email
idrisnsw83@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khyber Teaching Hospital, Peshawar
Full name of responsible person
Muhammad Idrees Khan
Street address
University Rd, Rahat Abad, Peshawar, Khyber Pakhtunkhwa, Pakistan
City
Peshawar
Postal code
25000
Phone
+92 91 5711751
Email
idrisnsw83@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khyber Teaching Hospital, Peshawar
Proportion provided by this source
25
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general 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 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
Data will be provided under the title importance of timing in craniotomy in Spontaneous intracereberal haemorrhage: experience in a Tertiary care hospital
When the data will become available and for how long
Data will be available after approval of RCT
To whom data/document is available
Data will be available to neurosurgeons and medical students
Under which criteria data/document could be used
Data will be used after approvla from principle author
From where data/document is obtainable
Data will be obtained through email to principle author
Muhammad Idris Khan
idrisnsw83@gmail.com
What processes are involved for a request to access data/document
Process is simple. Just the seeker have to email the author