Comparison of tranexamic acid administration and controlled hypotension or combination of them for bleeding reduction during craniocynostosis surgery in Imam Hossein Hospital in Isfahan in 2016-17
The assessment of the efficacy of tranexamic acid and controlled hypotension or a combination of both for the reduction in bleeding during craniosynostosis surgery
Design
Randomized double-blinded clinical trial without control group, with parallel-groups
Settings and conduct
The study will be conducted in Imam Hossein Hospital on infants who meet the inclusion criteria and are a candidate for craniosynostosis surgery under general anesthesia. Before the anesthesia induction, two venous lines were taken and blood transfusion will be initiated. Immediately following anesthesia induction in a similar pattern of 0,02mg/kg atropine, 5mg/kg sodium thiopental and 0.5mg/kg atracurium, the interventions will be done.
The legal guardians of the patients will be blinded to the type of intervention. Besides, the investigator who should gather the data in the study checklist will be blinded, as well.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Physical status of ASA I-II based on American Society of Anesthesiology
Unmet criteria:
- Cardiac disease
- Liver diseases
- Renal diseases
- Pulmonary diseases
-Congenital anomalies
Intervention groups
The first intervention group: 10mg/kg tranexamic acid
The second intervention group: Controlled hypotension at mean arterial pressure of 30mmHG less than what was measured before anesthesia induction or in range of 50-60mmHG
The third intervention group: 10mg/kg tranexamic acid plus controlled hypotension at mean arterial pressure of 30mmHG less than what was measured before anesthesia induction or in range of 50-60mmHG
Main outcome variables
Amount of bleeding; Amount of transfused blood and fresh frozen plasma; Duration of intensive care unit admission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190328043128N1
Registration date:2020-03-04, 1398/12/14
Registration timing:retrospective
Last update:2020-03-04, 1398/12/14
Update count:0
Registration date
2020-03-04, 1398/12/14
Registrant information
Name
Zahra Mazaheri Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3225 9771
Email address
zahra.mzht@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-05-10, 1396/02/20
Actual recruitment end date
2018-04-22, 1397/02/02
Trial completion date
2018-05-02, 1397/02/12
Scientific title
Comparison of tranexamic acid administration and controlled hypotension or combination of them for bleeding reduction during craniocynostosis surgery in Imam Hossein Hospital in Isfahan in 2016-17
Public title
Tranexamic acid, controlled hypotension or their combination for reduction in bleeding due to craniocynostosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Physical status of I-II based on American Society of Anesthesiology
Age of 3 months to 12 months
Each of the patients was provided with a particular number by Random Allocation software allocated them to an intervention group.
Each patient was provided with a particular number. Cases with numbers corresponded for 3*k were allocated to tranexamic acid treated group, those with numbers corresponded for 3*k+1 were allocated to controlled hypotension group and those with numbers corresponded for 3*k+2 were allocated to the groups treated with the combination of tranexamic acid and controlled hypotension
Blinding (investigator's opinion)
Double blinded
Blinding description
The legal guardians of the patients will be blinded to the intervention and the researcher who records the information will be blinded as well.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.MUI.REC.1396.3.597
Health conditions studied
1
Description of health condition studied
Bleeding during craniosynostosis
ICD-10 code
Q75.0
ICD-10 code description
Craniosynostosis
Primary outcomes
1
Description
Amount of bleeding
Timepoint
During the surgery
Method of measurement
Gradient container contained suctioned blood
2
Description
The amount of transfused blood
Timepoint
During the surgery and admission at intensive care unit
Method of measurement
Pack cell
3
Description
The amount of transfused fresh frozen plasma
Timepoint
During the surgery and admission at intensive care unit
Method of measurement
Pack cell
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group: Tranexamic acid; 10 mg/kg; Immediately after anesthesia induction
Category
Treatment - Drugs
2
Description
The second Intervention group: Controlled hypotension; The manipulation of mean arterial pressure at 30 mmHg less than mean arterial pressure before the anesthesia induction or regulation of mean arterial pressure at 50-60 mmHg; Immediately after anesthesia induction
Category
Treatment - Other
3
Description
The third Intervention group: Combination of Tranexamic acid with controlled hypotension; 10 mg/kg of tranexamic acid plus the manipulation of mean arterial pressure at 30 mmHg less than mean arterial pressure before the anesthesia induction or regulation of mean arterial pressure at 50-60 mmHg; Immediately after anesthesia induction
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Amir Shafa
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozhgan Mortazavi
Street address
Hezarjarib Street, Isfahan University of Medical Sciences, Vice chancellor for research
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mortazavi@med.mui.ac.ir
Web page address
http://med.mui.ac.ir/?q=pajoheshi/pajoheshi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences, Vice chancellor for Research affiliated at Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
shafa_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
shafa_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
shafa_amir@yahoo.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
The data of the present study are provided by the relevant professor and in the case of publishing new and related studies are provided
When the data will become available and for how long
Following the publication of the article in an international journal, the data are acceible
To whom data/document is available
Residents of anesthesiology who have a new proposal in this regard with the similar professor
Under which criteria data/document could be used
Only for publication of a new article with the relevant professor
From where data/document is obtainable
With the relevant anesthesiologist
What processes are involved for a request to access data/document
Following a call or an email to the relevant professor