Effect of Intravenous Tranexamic Acid on blood loss in Pelvic and Acetabular fractures in patients referred to Taleghani and Emam Hosein Hospital of Tehran between 2019-2020
Effect of Intravenous Tranexamic Acid on blood loss in pelvic and acetabular fractures
Design
A parallel group, double blind, randomized clinical trial consisting 108 patients. Random function in excel will be used to randomize the patients.
Settings and conduct
The study will be conducted on patients referred to Taleghani and Emam Hosein hospital in Tehran diagnosed with pelvic or acetabular fractures due to trauma. First of all patients will be randomized with random function in Excel into Intervention and control groups. The intervention group will receive 15 milligram/kilogram of Tranexamic Acid in 500 milliliters of normal saline 30 minutes before surgery intravenously. The control group will receive equivalent volume of normal saline 30 minutes before surgery. In this study patients and analyzer will be triple-blind. Medical data will be gathered by medical documents and the questionnaires filled out by patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Pelvic fracture
2-Acetabular fracture
Exclusion criteria:
1-Age below 18 years old
Intervention groups
Case group will receive 15 milligram/kilogram Intravenous Tranexamic Acid in normal saline.
Control group will receive equal volume of normal saline
Main outcome variables
blood loss; used packed cell(s); Estimated blood loss; age; gender; Body Mass Index(BMI); History of Coronary Artery diseases; History of diabetes; pre-operation hemoglobin level; post-operation hemoglobin level; weight of blood soaked gauze pads used during the surgery; history of hypertension; Duration of surgery; blood drained during first post-op 24 hours; confirmed symptomatic Deep Vein Thrombosis(DVT); incidence of Pulmonary ThromboEmbolism(PTE); Site of fracture(s); Type of fracture(s);Duration between occurrence of fracture and start of surgery; Post-op hospitalization days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039188N2
Registration date:2021-05-10, 1400/02/20
Registration timing:retrospective
Last update:2021-05-10, 1400/02/20
Update count:0
Registration date
2021-05-10, 1400/02/20
Registrant information
Name
Reza Zandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
reza.zandi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intravenous Tranexamic Acid on blood loss in Pelvic and Acetabular fractures in patients referred to Taleghani and Emam Hosein Hospital of Tehran between 2019-2020
Public title
Effect of Tranexamic Acid on blood loss in Pelvic and Acetabular fractures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pelvic fractures
Patients with acetabular fractures
Exclusion criteria:
Age below 18
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 2 groups (1 Control, and 1 intervention groups), will done using software, 54 random numbers for each group.
The surgeon can not play a role in predicting treatment of the disease, and choosing the type of treatment. Random sequence will generate by software.
All admitted patients will be placed in one of the groups according to the pre-determined code
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation concealment was assured using opaque, sealed envelopes. The anesthesia technician received the envelope and administered either tranexamic prior to the procedure. The patient was given general anesthesia and was unaware of the received treatment and remained blinded after surgery. Two envelopes with the same information about treatment allocation were created. The second envelope was given to the nurse for postoperative drug administration.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of medical sciences
Fracture of unspecified parts of lumbosacral spine and pelvis
Primary outcomes
1
Description
Estimated blood loss during surgery
Timepoint
End of surgery
Method of measurement
Estimated Blood Loss(in milliliter)=1000*((hemoglobin level before sugery - hemoglobin after surgery) * total body volume + transfused allogeneic hemoglobin)
2
Description
Post-op drained blood
Timepoint
Last day of hospitalization
Method of measurement
Perception and by using drainage bag
Secondary outcomes
1
Description
vein thrombosis of lower limb
Timepoint
three months
Method of measurement
color doppler ultrasonography if patient has related symptoms
2
Description
Pulmonary embolism
Timepoint
three months
Method of measurement
Lung CT angiography if patient has related symptoms
3
Description
Drug-associated reaction
Timepoint
three months
Method of measurement
Questionnaire based on drug-associated reaction symptoms answered by patient
Intervention groups
1
Description
Intervention group: Intervention group will receive 15 milligrams per kilogram intravenous tranexamic acid dissolved in 500 milliliters of normal saline 30 minutes prior to start of surgery.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive equivalent volume of normal saline 30 minutes prior to start of surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Reza Zandi
Street address
Aarabi street-Yaman street-Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
reza.zandi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
ُُShahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
reza.zandi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Aarabi st.-Yaman st.-Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
reza.zandi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
3545415545
Phone
+98 21 2240 2020
Email
reza.zandi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Aarabi St.- Yaman St.-Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
reza.zandi@sbmu.ac.ir
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
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
The data including age, gender, history of diseases (Coronary artery disease, diabetes and Hypertension) and other considered variable will be shared after deidentification.
When the data will become available and for how long
Data will be available in 6 months after publication.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Any type of analysis is prohibited unless the person in charge of the research is informed and would permit.
From where data/document is obtainable
Reza Zandi
Address: Aarabi St. - Yaman St. - Shahid Chamran Highway - Tehran
Email: reza.zandi@sbmu.ac.ir
What processes are involved for a request to access data/document
Doing the letter writing
accordance with the person in charge of the research