Investigating the effect of local, oral and intravenous tranexamic acid on the amount of bleeding during humerus fracture surgery
Design
The study will be double blind and clinical trial.90 patients will be randomly divided into 3 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients with humerus fracture surgery in valiasr Hospital in Arak are divided into 3 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients with ASA class 1 and 2, all patients with humerus fracture, all patients candidates for elective surgery, 18 to 70 years, patients with BMI greater than 30. Exclusion criteria: pregnancy, underlying kidney, heart, lung and liver disease, candidate patients for general anesthesia; sensitivity to tranexamic acid, no consent to participate in the study.
Intervention groups
Intervention group 1: patients will receive 20 mg/kg tranexamic acid IV.
Intervention group 2: Patients receive 1 gram of tranexamic acid orally 1 hour before surgery with 1 glass of water.
Intervention group 3: 3 grams of topical tranexamic acid will be placed in contact with the operation site.
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N184
Registration date:2023-05-29, 1402/03/08
Registration timing:prospective
Last update:2023-05-29, 1402/03/08
Update count:0
Registration date
2023-05-29, 1402/03/08
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of local, oral and intravenous tranexamic acid on the amount of bleeding during humerus fracture surgery
Public title
Investigating the effect of local, oral and intravenous tranexamic acid on the amount of bleeding during humerus fracture surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with ASA class 1 and 2
All patients with humerus fracture
All patients candidates for elective surgery
18 to 70 years
Patients with BMI greater than 30
Patients candidate for general anesthesia
Exclusion criteria:
Pregnancy
Underlying kidney, heart, lung, and liver disease
Sensitivity to tranexamic acid
No consent to participate in the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into3 groups using a permuted balanced block randomization method with the size of blocks 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the specialized assistant does not know about the prescribed drugs, and the follow-up of the patients is with the orthopedic assistant, and the analyst does not know about the grouping, and as a result, the study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2023-05-07, 1402/02/17
Ethics committee reference number
IR.ARAKMU.REC.1402.036
Health conditions studied
1
Description of health condition studied
Humerus fracture
ICD-10 code
M80.02
ICD-10 code description
Age-related osteoporosis with current pathological fracture, humerus
Primary outcomes
1
Description
Bleeding
Timepoint
During the operation, recovery and 24 and 48 hours after the operation
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: patients will receive 20 mg/kg tranexamic acid IV.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients receive 1 gram of tranexamic acid orally 1 hour before surgery with 1 glass of water.
Category
Treatment - Drugs
3
Description
Intervention group 3: 3 grams of topical tranexamic acid will be placed in contact with the operation site.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Mohsen Parsi khameneh
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
parsi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Mehdi @arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Parsi Khameneh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
parsi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Parsi Khameneh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street