Effectiveness of Tranexamic Acid in reducing bleeding and blood transfusion in hystrectomy.
Design
Randomized, blinded, controlled clinical trial with a parallel-group design of 60 patients
Settings and conduct
This study was done in Shahid Beheshti Hospital in Isfahan in years 2016-2017.Tranexamic acid injection was prepared by diluting1 gr (10 mL) tranexamic acid with 20 mL of 5% glucose and it was injected 20 min before the incision. If patients had sign of hemodynamic instability due to blood loss (heart rate >120 beats/min or a systolic blood pressure decrease by more than 20% of base value) despite adequate volume replacement, blood transfusion was given.
All patients’ preoperative and 12th hour postoperative blood samples were analyzed for hemoglobin, hematocrit,platelet count,INR,prothrombin time (PT), activated partial thromboplastin time (aPTT).
The study was double-blinded with the patient and caregiver(surgeon and anesthesiologist). they were not aware of the treatment of the groups.
Participants/Inclusion and exclusion criteria
Female patients of 35 to 70 years; American society of anesthesiologists (ASA) physical status class I and II; scheduled for either vaginal or abdominal hysterectomy,were enrolled for the study.
Exclusion criterion were allergy to tranexamicacid; anemia; preoperative hepatic or renal dysfunction; serious cardiac or respiratory disease; ASA phisycal status morer than 2; congenital or acquired coagulopathy or a history of deep vein thrombosis or thromboembolic disease.
Intervention groups
This study investigated the effect of tranexamicacid on control of bleeding and the need for transfusion in case and control groups.
Main outcome variables
bloodloss; blood transfusion؛ hemoglobin level ؛operation time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210703051769N1
Registration date:2021-08-22, 1400/05/31
Registration timing:retrospective
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Ensiyeh Bahadoran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 0923
Email address
bahadoran.ensiyeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
2018-01-21, 1396/11/01
Scientific title
Assessment of effect of intravenus tranexamic acid on hemorrhage reduction during and after hysteretomy in comparison with control group
Public title
Assessment of effect of Tranexamic acid on hemorrhage reduction in hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate of vaginal or abdominal hystrectomy
Between 35-70 years old
American society of anesthesiologist (ASA) grade for physical status 1 or 2
Exclusion criteria:
Anemia
Hepatic dysfunction
Renal dysfunction
Serious cardiac disease
Serious respiratory disease
Acquired or congenital coagulopathy
Previous history of deep venus thrombosis or thromboembolic disease
ASA more than 2
Sensitive to tranexamicacid
Age
From 35 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
With Random allocation software patients got numbers from 1 to 60.If the paitient had even numder it has entered to T group and if the patient had odd numder it has entered to S group.Group T recieved 1 gr tranexamic acid,in the other hand group S recieved the same amount of normal saline.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, clinical caregiver and patients participating in the study were blind. All patients were aware of the benefits and the adverse effects of clinical trial, but they were unaware about who received the intervention. Clinical caregiver, surgeon and anesthesiologist were blind. Tranexamic acid was administered 20 minutes before the surgery by an anesthesiologist.Some of them received placebo (normal saline solution).
Placebo
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 Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-07-02, 1396/04/11
Ethics committee reference number
IR.MUI.REC.1396.3.201
Health conditions studied
1
Description of health condition studied
Hysterectomy
ICD-10 code
Z90.710
ICD-10 code description
Acquired absence of both cervix and uterus
2
Description of health condition studied
Blood transfusion
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Tranexamic acid
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
blood loss
Timepoint
During and after sugery
Method of measurement
During the surgery by weighting swabs,spinges,operative drapes and measuring the volume in suction buttles after surgery by measuring the drain collectors in post anesthesia care unit.
2
Description
Blood transfusion
Timepoint
During and 12 hours after surgery
Method of measurement
Pack cell
Secondary outcomes
1
Description
Hemoglobin
Timepoint
During and 12 hours after surgery
Method of measurement
Blood test
2
Description
Hematocrit
Timepoint
Before and 12 hours after surgery
Method of measurement
Blood test
3
Description
Operation time
Timepoint
Operation time
Method of measurement
Timer
Intervention groups
1
Description
Intervention group: recieve 1 gr tranexamic acid as slow intravenus bolus.Tranexamic injection was prepared by diluting 1 gr (10ml) tranexamic acid with 20 ml of5% glucose.
Category
Treatment - Drugs
2
Description
Control group: recieve equal volume of normal saline (10ml).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Ensiyeh Bahadoran
Street address
West Motahari Street,Felezi Bridge
City
Isfahan
Province
Isfehan
Postal code
8184853542
Phone
+98 31 3234 6340
Email
Beheshti@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Building Number 4, Isfahan Medical Univesity, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
Sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Qazvin University of Medical Sciences
Full name of responsible person
Ensiyeh Bahadoran
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No 21, Bahman Alley, Padegan Street
City
Qazvin
Province
Qazvin
Postal code
3415697171
Phone
+98 28 3333 0923
Email
Bahadoran.ensiyeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Azadeh Bahadori
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Azadeh.bahadori93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ensiyeh Bahadoran
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No 21, Bahman Alley, Padegan Street
City
Qazvin
Province
Qazvin
Postal code
3415697171
Phone
+98 28 3333 0923
Email
Bahadoran.ensiyeh@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after unidentifiable individuals.
When the data will become available and for how long
6 month after publication,data will be accessible.
To whom data/document is available
The study will be available for researchers who work in academic and scientific institutions.
Under which criteria data/document could be used
Due to the unrecognizable people,no restriction will apply.