investigate efficacy of fibrinogen blood level correction between 1.5 - 2 gr/lit to above 2 gr/lit with bleeding rate during operation and post operation hospital course in traumatic brain injury
the evaluation of relation between correction of fibrinogen level (1.5-2.0 grm/lit) in traumatic brain injury to > 2.0 grm/lit and peri operational bleeding
Design
randomizaing with coin flipping (head or tail), parallel group trial with blinded outcome and data collection,
sample volume will be chosen by explained duration ( between March 2019 to March 2020) according to numbers and data of samples we will colected
Settings and conduct
patients who underwent craniotomy whom fibrinogen level is between 1.5 to 2.0 gr/lit are include and we exclude patients who have coagulopathy in lab data like abnormal PT,PTT,INR, platelets counts or coagulopathy disorders history or underwent another major surgery. patients are devided to patients whose fibrinogen level are corrected to > 2.0 gr/lit and the rest by randomizaing with coin flipping (head or tail), None of patients, sergeuns and who collect data know about grouping of paitents. in this study we compare bleeding valume in peri operative priods and increasing ratio of bleeding of peri operative brain CT scan in non operative sites.
Participants/Inclusion and exclusion criteria
patients who are brought to Emtiaz hospital ER, affiliated to Shiraz Univercity of medical sciemces,Shiraz, Iran, between March 2019 to March 2020 and underwent craniotomy whom fibrinogen level is between 1.5 to 2.0 gr/lit are include in our study
patients who have coagulopathy in lab data such as abnormal PTwe exclude the patients who have coagulopathy in lab data such as abnormal PT,PTT,INR, platelets counts or history of coagulopathy disorders or underwent another major surgery from other services in this admission before skull craniotomy surgery from our study
Intervention groups
correction of serum fibrinogen level (1.5-2.0 grm/lit) to > 2.0 grm/lit
Main outcome variables
peri operative bleeding valume rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190129042541N1
Registration date:2019-02-13, 1397/11/24
Registration timing:prospective
Last update:2019-02-13, 1397/11/24
Update count:0
Registration date
2019-02-13, 1397/11/24
Registrant information
Name
amin niakan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 4206
Email address
aniakan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigate efficacy of fibrinogen blood level correction between 1.5 - 2 gr/lit to above 2 gr/lit with bleeding rate during operation and post operation hospital course in traumatic brain injury
Public title
investigate efficacy of fibrinogen blood level correction and bleeding valume in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are older than sixteen years and brought to Emtiaz hospital ER, affiliated to Shiraz Univercity of medical sciemces,Shiraz, Iran, between March 2019 to March 2020 and underwent skull craniotomy whom fibrinogen level is between 1.5 to 2.0 gr/lit are include in our study
Exclusion criteria:
patients who have coagulopathy in lab data such as abnormal PTwe exclude the patients who have coagulopathy in lab data such as abnormal PT,PTT,INR, platelets counts or history of coagulopathy disorders or underwent another major surgery from other services in this admission before skull craniotomy surgery from our study
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
randomizaing with coin flipping (head or tail), if flipped coin shows head (picture side of coin) ,we put patient in fibrinogen corrected group and if flipped coin shows tail (amount of money coin side coin) ,we put patient in fibrinogen in uncorrected group
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
•Ethics committee of Shiraz University of Medical Sciences
Street address
Emtiaz Hospital, shahid chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.SUMS.MED.REC.1397.340
Health conditions studied
1
Description of health condition studied
intra cranial bleeding in traumatic brain injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
blood volume rate
Timepoint
pre operatio and post operation
Method of measurement
blood volume messurment during operation and in hemovac and post operatin, blood volume messurment in pre and post operation CT scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pre operation or during surgery intra venous fibrinogen injection was down patient. , if serum fibrinogen level is between 175 to 200 mg per lit, one gram fibrinogen was injected ,and if serum fibrinogen level is between 150 to 200mg per lit, two gram fibrinogen was injected
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emtiaz hospital
Full name of responsible person
Amin Niakan
Street address
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3625 4206
Email
aniakan@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor of research . shiraz university of medical sciences
Full name of responsible person
younes ghasemi
Street address
7th floor, Central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor of research . shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amin Niakan
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3625 4206
Email
aniakan@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amin Niakan
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3625 4206
Email
aniakan@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amin Niakan
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3625 4206
Email
aniakan@sums.ac.ir
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
No - There is not 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 except personal patients data
When the data will become available and for how long
6 months after data publication
To whom data/document is available
all researcher
Under which criteria data/document could be used
no extra condition
From where data/document is obtainable
researcher should refer to emtiaz hospital
What processes are involved for a request to access data/document