Determination and evaluation of the effect of cryopericipitate on pervention of brain contusion expansion during the first 24 hours in traumatic patients.
Design
The randomized double blind clinical trial with two groups including intervention and control groups. Randomization is done through blocks with size of six and eight and online software. Sample size in each group is 25 patients.
Settings and conduct
Traumatic patients over 18 y/o and non_ pregnant who are brought to Kermanshah Talighani hospital and have brain contusion or intracerebral hemorrhage; after obtainlegal consent; will be divided into 2 groups. Patients themselves, planner and data collector do not know who is in the control and who is in the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: traumatic brain contusion or brain hematoma; over 18 years of age; their legal guardian allowance.
Non-inclusion criteria: history of blood hemostatic factor deficiency; candidate for emergency brain hemorrhage surgery; pregnancy
Intervention groups
In the control group all standard measures including anticonvulsants , normal saline ,laberatory tests and thight control of level of consciousness will be performed. In the intervention group four units of cryopreciptate will be administered at the first time after confirmation of the diagnosis in addition to the standard treatments administered in the control group.
Main outcome variables
Intraparanchymal hematoma size of brain tissue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190729044375N1
Registration date:2021-01-31, 1399/11/12
Registration timing:prospective
Last update:2021-01-31, 1399/11/12
Update count:0
Registration date
2021-01-31, 1399/11/12
Registrant information
Name
Alireza Tahmoures
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 7989
Email address
alireza.tahmoures@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare the effect of cryopericiptate and conventional treatment on prevention of brain contusion expansion in trauma patients
Public title
Effect of cryopercipitate in trauma patients with brain contusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic brain contusion or brain hematoma
Over 18 years of age
Their legal guardian allowance
Exclusion criteria:
History of blood hemostatic factor deficiency
Candidate for emergency brain hemorrhage surgery
Pregnancy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using the block randomization method individuals are divided into two equal groups. Randomization process will be done using blocks of size 6 and 8. Blocking will already be done by random software online.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind_The physician who collects data, the physician who is responsible for patient care, the analyst and the patient included in the plan are unaware of who receives cryopercipitate or or is in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medicine Sciences
Street address
Taleghani hospital; Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.KUMS.REC.1399.945
Health conditions studied
1
Description of health condition studied
Brain contusion expansion in traumatic patients(ICH; IVH, Brain Contusion)
ICD-10 code
S06.3
ICD-10 code description
Focal traumatic brain injury
Primary outcomes
1
Description
Size of brain tissue hematoma
Timepoint
At the time of admission and 6, 12, 24 and 48 hours after admission
Method of measurement
Size determination on CT scan graph by radiologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receivig conservative routine care; intravenous adminestration of 4 units of cryoprecipitate prepared in Iranian Blood Transfusion Organization which contains coagulation factors (fibrinogen& 8&13&VWF) in nonpregnant traumatic patient above 18y/o who have no history of blood factor deficiency disease.( routine and conservative care:ICU admission and control of GCS and anticonvulsant therapy)
Category
Treatment - Drugs
2
Description
Control group:In this grouo patients with brain contusion due to trauma who are nonpregnant; above18y/o and have no history of blood factor deficiency disease are only under routine conservative care(ICU admission and control of GCS and anticonvulsant therapy).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Taleghani hospital
Full name of responsible person
Dr.Mohammadreza Akrami
Street address
Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 8098
Email
alireza.tahmoures@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Kermanshah University of Medical Sciences
Street address
Taleghani hospital; Shahid beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 8098
Email
alireza.tahmoures@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Mohamamdreza Akrami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Taleghani hospital; Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 8098
Email
alireza.tahmoures@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Akrami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Taleghani hospital; Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
671584167
Phone
+98 83 3835 7752
Email
alireza.tahmoures@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohamadreza akrami
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Taleghani hospital; Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
7417994745
Phone
+98 83 3835 7752
Email
alireza.tahmoures@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
All data collected in the research (including: age, gender, height, weight, lab.data and radiologic finding) can be shared after making people unidentifiable.
When the data will become available and for how long
Three months after announcement the results
To whom data/document is available
Only researchers working in academic institution
Under which criteria data/document could be used
This research will be done on limitted number of people; but its results can be cited in meta_ analyze.
From where data/document is obtainable
Dr. Mohammd Reza Akrami. Address: Department of neurosurgery; Taleghani hospital affiliated to Kermanshah University of Medical Sciences. Email address: mmdakramu@yahoo.com
What processes are involved for a request to access data/document
After confirming that the applicant has the conditions to receive the information ( the researcher working in a university or scientific institute) the information will be provided to him/ her as soon as possible.