To assess the effect of oral Transexamic acid versus placebo on hemorrhage during spinal surgery
Design
This is a Phase III double-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan city, involving 98 eligible patients who are candidate for spinal surgery. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Candidate for spine surgery
Exclusion criteria:
Spine surgery
Renal failure
Taking anticoagulants
Intervention groups
Intervention group:
Routine preoperative care plus Tranexamic acid tablets orally 10 mg/kg 24 hours before surgery
Control group:
Routine pre-operative care plus a placebo pill (containing starch) 24 hours before surgery
Main outcome variables
Primary outcome:
Hemoglobin level, the volume of blood lost, the amount of blood received
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N506
Registration date:2024-04-02, 1403/01/14
Registration timing:prospective
Last update:2024-04-02, 1403/01/14
Update count:0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Transexamic acid versus placebo on hemorrhage during spinal surgery: a double-blind randomized clinical trial
Public title
Effect of oral Transexamic acid versus placebo on hemorrhage during spinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Candidate for spine surgery
Exclusion criteria:
Spine surgery
Renal failure
Taking anticoagulants
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be performed using block randomization. To achieve this, six sheets of paper will be prepared - three with the name of "Intervention 1," and three with the name of "Control." These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.UMSHA.REC.1402.234
Health conditions studied
1
Description of health condition studied
Spinal surgery
ICD-10 code
G95
ICD-10 code description
Other and unspecified diseases of spinal cord
Primary outcomes
1
Description
Hemoglobin level
Timepoint
Before the intervention and 24 hours later
Method of measurement
By taking a blood sample
2
Description
The volume of blood lost
Timepoint
During surgery
Method of measurement
By measuring the output volume of suction
3
Description
The amount of blood received
Timepoint
During surgery
Method of measurement
Based on the medical record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine preoperative care plus Tranexamic acid tablets orally 10 mg/kg 24 hours before surgery
Category
Treatment - Drugs
2
Description
Control group: Routine pre-operative care plus a placebo pill (containing starch) 24 hours before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Soroush Shekoufandeh
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
soroushshekoufandeh@ gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Soroush Shekoufandeh
Position
Resident of Neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
soroushshekoufandeh@ gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Arjipour
Position
Neurosurgeon
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mahdiarjipour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available