Comparison of systemic Tranexamic acid injection with topical in reduction of bleeding during and after spinal surgery
Design
The study is a randomized, community-based, and pragmatic clinical trial consisting of 100 patients in 2 parallel groups with a double-blind design
Settings and conduct
This study will be carried out at Tabriz Imam Reza Hospital in a two-blind manner,
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) patients aged 15 to 75 years 2). Candidates to the spinal fixation surgery Agreed to participator.3) Having informed consent to participate in the study. Exit criteria: 1. History of abnormal bleeding 2. Platelet is less than 150 thousand 3. History of Thrombosis 4. Consumption of interfering drugs with blood Homeostasis 5. Overweight (BMI>30)
Intervention groups
Intervention group1: Systemic tranexamic acid in first before the skin incision 10 mg per kg body weight as the initial bolus dose and then 1 mg per kg body weight every hour until the end of surgery by infusion.Intervention group 2: The same conditions continue as in intervention group 1, but eventually a topical dose of 50 mg per ml as a solution of normal saline will be used for the required serum consumption for rinsing from the beginning to the end of the operation.
Main outcome variables
Bleeding، Length of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N14
Registration date:2021-12-19, 1400/09/28
Registration timing:registered_while_recruiting
Last update:2021-12-19, 1400/09/28
Update count:0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of systemic Tranexamic acid injection with topical in reduction of bleeding during and after spinal surgery
Public title
systemic Tranexamic acid injection with topical in spinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates to the spinal fixation surgery
Agreed to participator
Exclusion criteria:
History of abnormal bleeding
Platelet less than 150 thousands
History of Thrombosis
Consumption of interfering drugs with blood Homeostasis
Overweight (BMI>30)
Age
From 15 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals were assigned to two groups using the permutation block method. In this method, a represents the individual receiving the systemic tranexamic acid and B represents the individual in the topical tranexamic acid group. Considering the quadruple block; they were classified into AABB, ABAB, ABBA, BAAB BBAA, and BABA permutations, and by random selection from permutation patients were classified
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment assessor and the statistical analyst will not be aware of the allocation of intervention until the end of the study.se group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
Azadi Ave , Golghast St , Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2021-07-12, 1400/04/21
Ethics committee reference number
IR.TBZMED.REC.1400.363
Health conditions studied
1
Description of health condition studied
The effect of Tranexamic Acid for bleeding in Spinal Surgery
ICD-10 code
D69.9
ICD-10 code description
Hemorrhagic condition, unspecified
Primary outcomes
1
Description
Bleeding
Timepoint
During surgery till 48 hours after surgery
Method of measurement
Number of pads and amount of suction blood during surgery
Secondary outcomes
1
Description
Length of hospitalization during laminectomy and in spinal fusion
Timepoint
During surgery and duration of hospitalization after surgery
Method of measurement
Duration of hospitalization in hospital days
2
Description
the amount of blood collected in hemovac in patients undergoing laminectomy and in spinal fusion
Timepoint
Duration of hospitalization after surgery
Method of measurement
The amount of blood accumulated in CC
Intervention groups
1
Description
Intervention group: Systemic tranexamic acid in first before the skin incision 10 mg per kg body weight as the initial bolus dose and then 1 mg per kg body weight every hour until the end of surgery by infusion
Category
Treatment - Surgery
2
Description
Intervention group 2: The same conditions continue as in intervention group 1, but eventually a topical dose of 50 mg per ml as a solution of normal saline will be used for the required serum consumption for rinsing from the beginning to the end of the operation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
Ali Asghar Asghari
Street address
Azadi St. Golghast St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 5094
Email
ali.tmv@gmail.com
Web page address
https://imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
Meshkinia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farhad Mirzaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
golzar.farhad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farhad Mirzaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street