Effect of Tranexamic Acid on Blood Loss and transfusion in Femoral Fixation Surgeries
Design
A clinical trial with a parallel control group, do not blind, randomized
Settings and conduct
In this clinical trial, 60ASA class I and II patients, aged 16-65 years old, who were candidates for femoral fixation surgery, were randomly divided into two groups receiving Tranexamic acid(TXA) and control. In the TXA group, 30 minutes before surgery, an intravenous dose of 15 mg/ kg of Tranexamic acid was administered, and the 2nd group(control) received the same volume(200ml) of normal salin. Blood Loss, need for blood transfusions, platelet count, hematocrit, coagulation tests, and hemoglobin levels before and after surgery were recorded and compared in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages between 16 and 65 years old; ASA Class 1 and 2; Exclusion criteria: History of coagulopathy and bleeding disorders; Renal impairment; History of using antiplatelet and anticoagulant; Acute infection; A history of malignancy and ASA above 2 and thromboembolic events; Hemoglobin levels less than 10; Sensitivity to tranexamic acid
Intervention groups
Patients were divided into two groups, receiver transexamic acid (TXA) and control.
Effect of Tranexamic Acid on Blood Loss and transfusion in Femoral Fixation Surgeries
Public title
Effect of Tranexamic Acid on Blood Loss and transfusion in Femoral Fixation Surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 16 and 65 years old
ASA Class 1 and 2
Exclusion criteria:
History of coagulopathy and bleeding disorders
Renal impairment
History of using antiplatelet and anticoagulant
Acute infection
A history of malignancy and ASA above 2 and thromboembolic events
Hemoglobin levels less than 10
Sensitivity to tranexamic acid
Age
From 16 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups randomly by software using simple randomization.
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 Hormozgan University of Medical Sciences
Street address
Deputy of research and technology, the Supreme Prophet's Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
HUMS.REC.1394.59
Health conditions studied
1
Description of health condition studied
Femoral Fixation Surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin level
Timepoint
On the first day after surgery
Method of measurement
measurement
2
Description
bleeding rate
Timepoint
After surgery at 6, 12, 24 hours after surgery
Method of measurement
measurement
3
Description
blood transfusion rate
Timepoint
During surgery and within 24 hours after surgery
Method of measurement
measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The trans-oxamic acid-receiving group was injected intravenously 30 min before surgery with a 15 mg / kg dose of tranexamic acid.
Category
Treatment - Drugs
2
Description
Control group: In control group, only normal saline was injected with equal volume of 200ml for 20 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital of Bandar Abbas
Full name of responsible person
Hashem Jarineshin
Street address
Boulevard of the Islamic Republic of Iran, Bandar Abbas, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Email
Anrc.hums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abdul Azim Nejati Zadeh
Street address
Deputy of research and technology, East Side, Bandar Abbas Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 71 3333 5794
Email
azimnejate @yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.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
No - There is not 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
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
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Shahid mohammadi hospital
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.