This study aimed to evaluate the effect of oral Tranexamic acid (TXA) on the amount of bleeding during spine surgery.
Design
A Randomized Double-Blind, Placebo-controlled Clinical Trial
Settings and conduct
patients with lumbar spinal cord and back pain disease, who needed fusion or were candidates for bilateral or more or equal to two levels surgeries, referred to the Department of Neurosurgery, were included. All patients eligible for inclusion in the study were randomly divided into two equal groups (double-blind). The intervention group included 64 patients who received 25 mg/kg of TXA four times a day before the surgery and 500 mg in the morning of surgery. Placebo group included 65 patients who received the placebo. It should be noted that the subjects (patients) and researcher (Neurosurgery resident) are not aware of the type of medication.
Participants/Inclusion and exclusion criteria
Participants: patients with lumbar spinal cord and back pain disease; inclusion criteria: being in a range of ages 18-60, lack of cardiovascular disease, discopathies with spinal fusion, and discopathies more than two levels or two-sided spinal cord; exclusion criteria: dissatisfaction to participate in the study, abnormal bleeding, platelet count < 150,000 (k), a history of thrombosis or embolism, severe allergies, use of intermittent medications with hemostasis in the blood, high blood pressure uncontrolled (PB> 160/90), obese people (BMI> 30)
Intervention groups
The intervention group will receive 25 mg/kg of Tranexamic Acid orally four times a day before the surgery and 500 mg in the morning of surgery. The placebo group will also receive a total dose of 2-g small pills that are identical in appearance but contained no active ingredient.
Main outcome variables
The amount of bleeding in patients during the operation will be calculated based on the count of blood gases and suction content.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190525043701N1
Registration date:2019-08-02, 1398/05/11
Registration timing:prospective
Last update:2019-08-02, 1398/05/11
Update count:0
Registration date
2019-08-02, 1398/05/11
Registrant information
Name
Normohammad Mamizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 9452
Email address
mamizadeh.n@ajums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-10-02, 2019/07/10
Expected recruitment end date
2641-03-11, 2019/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Tranexamic Acid for bleeding in Spinal Surgery
Public title
Oral Tranexamic Acid in Spinal Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being in a range of ages 18 to 60
lack of cardiovascular disease
Patients undergoing lumbar and back spine surgery, including discopathies with spinal fusion, and discopathies more than two levels or two-sided spinal cord.
Exclusion criteria:
unwillingness to participate in the study
abnormal bleeding
platelet count less than 150,000 (k)
a history of thrombosis or embolism
severe allergies
using drugs that interact with hemostasis in the blood
high and uncontrolled blood pressure (blood pressure mre than 160/90)
obese people (body mass index more than 30).
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized on the basis of random numbers table in two groups of recipients TXA (n = 64) and placebo recipients (n = 65). All surgical procedures in this study were performed by a surgical team and the technique used was similar. The randomization in this study will be done as TXA group (25 mg/kg) received four tablets of 500 mg and the placebo group also received a full dose of 2 mg of small pills that appeared to be the same but dose not contain any active substance.
Blinding (investigator's opinion)
Double blinded
Blinding description
the subjects (patients) and researcher (Neurosurgery resident) are not aware of the type of medication. After collecting the data and the results of their analysis by the implementer, the type of each drug is identified and all surgeries are performed to control the confounding factors by a surgeon, and there is only one anesthesiologist for all patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences’ Ethics Committee
Street address
Golestan Blvd., Farvardin Street
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Approval date
2018-02-14, 1396/11/25
Ethics committee reference number
IR.AJUMS.REC.1396.1125
Health conditions studied
1
Description of health condition studied
The effect of oral Tranexamic Acid for bleeding in Spinal Surgery
ICD-10 code
D69.9
ICD-10 code description
Hemorrhagic condition, unspecified
Primary outcomes
1
Description
The amount of Bleeding after Oral Administration of Tranexamic acid
Timepoint
Before and after intervention will measure.
Method of measurement
The amount of blood collected in cc
Secondary outcomes
1
Description
The coagulation tests
Timepoint
Will be checked during and 72 hours after the operation.
Method of measurement
According to standard one-stage APTT method
Intervention groups
1
Description
Intervention group: Patients aged 18 to 60 years who are candidates for spinal surgery for any cause other than trauma, will be used on the day before surgery and 500 mg on the morning of surgery of the Trancehexamic acid (TXA) .
Category
Treatment - Drugs
2
Description
Control group: Patients between the ages of 18 and 60 who are candidates for spinal surgery for any reason other than trauma will be used placebo pills on the day before surgery and 500 mg in the morning of surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Nour Mohammad Mamizadeh
Street address
Golestan blv
City
Ahvaz
Province
Khouzestan
Postal code
6153715794
Phone
+98 61 3336 7562
Fax
+98 61 3336 7562
Email
mhmdmamizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badavi
Street address
Golestan blv
City
Ahvaz
Province
Khouzestan
Postal code
6153715794
Phone
+98 61 3336 7562
Fax
+98 61 3336 7562
Email
Research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nour Mohammad Mamizadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Golestan Blvd., Farvardin Street
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
mhmdmamizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nour Mohammad Mamizadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Golestan Blvd., Farvardin Street
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
mhmdmamizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nour Mohammad Mamizadeh
Position
Nour Mohammad Mamizadeh
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Golestan Blvd., Farvardin Street
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
mhmdmamizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Title and more details about the data/document
All collected data will be available.
When the data will become available and for how long
starting in January 2020
To whom data/document is available
Not only people working in academic institutions also people working in businesses can also apply to receive data.
Under which criteria data/document could be used
There are no other conditions.
From where data/document is obtainable
Applicants can apply for this by e-mail.
What processes are involved for a request to access data/document