Protocol summary

Study aim
Determine the role of oral Tranexamic Acid prophylactic effect in the prevention of bleeding surgery for knee replacement
Design
This clinical trial is based on community-based and pragmatic control group with parallel groups. Patients are divided into two groups by simple random sampling .Sample size is 30 patients who are candidates for knee replacement surgery
Settings and conduct
This study was performed on patients undergoing knee replacement surgery at Khatam-ol-Anbia Sharood Hospital.
Participants/Inclusion and exclusion criteria
Entry requirements: 1.The patient has a specific disease history such as kidney disease, liver disease, history of myocardial ischemia, hypertension, history of brain ischemia, and thromboembolic events. 2.Patients do not use aspirin or any other anticoagulants from the week prior to surgery: Plavix, Heparin, Enoxaparin, Warfarin. 3.Do not observe a specific diet (not just vegetarian or non-meat-eaters or use of certain substances that can interfere with blood parameters) 4.The patient do not use certain medications, such as supplements, iron and other drugs associated with blood tests. Exclusion criteria: ۱.Patient dissatisfaction to continue participation 2.Patients with abnormal clotting parameters (PT, PTT, BT, INR, platelet) 3.People with high systolic blood pressure (185 on the day of surgery) 4. During surgery and up to 6 hours after the operation, the osmotic arterial pressure is more than 20%.
Intervention groups
The intervention group: consisted of 15 patients who took oral capsules of 250 mg Tranexamic Acid every 6 hours. They used a total of 2 g before surgery. The control group: included 15 patients entered the study according to entry criteria and get only routine care.
Main outcome variables
Bleeding during and after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190220042773N1
Registration date: 2019-04-09, 1398/01/20
Registration timing: registered_while_recruiting

Last update: 2019-04-09, 1398/01/20
Update count: 0
Registration date
2019-04-09, 1398/01/20
Registrant information
Name
aboutaleb safdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 7627
Email address
aboutaleb.safdari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-07-16, 1398/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of oral Tranexamic Acid on bleeding in knee replacement surgery
Public title
Prophylactic effect of oral Tranexamic Acid on bleeding in knee replacement surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's full conditions for participation in the study and signature of the prepared form of the informed consent A person with a history of specific disease, such as kidney disease, liver disease, history of ischemia, heart, hypertension, history of self-sacrifice and signs of disability in the diagnosis and treatment of disability. Patients do not use aspirin or any other anticoagulants from the week before surgery: Plavix, heparin, enoxaparin, and warfarin. Do not observe a specific diet (it's not just herbivorous or meat-eaters, or the use of certain substances that lower blood glucose levels) Do not use special medication such as iron or other medications associated with bleeding.
Exclusion criteria:
Patient dissatisfaction to continue participation Patients with abnormal clotting parameters (PT, PTT, BT, INR, platelet) People with high systolic blood pressure (185 in surgery day) During surgery and up to 6 hours after the operation, the osmotic arterial pressure is more than 20%. Patients with complications such as nausea and vomiting, color blindness, headache and dizziness, thromboemboli, myocardial ischemia and nutritional ischemia before and after surgery.
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
None
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Islamic Azad University, Shahrood Branch
Street address
Shahrood, Shahr Branch, Islamic Azad University, Shahr
City
Shahrood
Province
Semnan
Postal code
43189- 36199
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.038

Health conditions studied

1

Description of health condition studied
Joint knee replacement hemorrhage
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Volume of bleeding in knee replacement surgery
Timepoint
During surgery and 6 hours after surgery and 12 hours after knee replacement
Method of measurement
Level of hemoglobin and platelets, PT, PTT, BT before and after the operation, the amount of blood lost through surgical suction bottles, weighing the used gauzes during surgery and blood on the field of postoperative surgery patients

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group: consisted of 15 patients who took oral capsules of 250 mg Tranexamic Acid every 6 hours They used a total of 2 g 2 day before knee replacement surgery.
Category
Prevention

2

Description
Control group : included 15 patients candidate knee replacement surgery entered the study according to entry criteria And doing no extra work
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital in Shahrood
Full name of responsible person
Aboutaleb Safdari
Street address
Shahrood, University of Blvd., Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
43189- 36199
Phone
+98 23 3239 0077
Fax
Email
aboutaleb.safdari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aboutaleb Safdari
Street address
Shahroud, University of Blvd., Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3239 0077
Email
aboutaleb.safdari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr Yousef Kolookhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahrood, University of Blvd., Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3239 0077
Email
dryousefkolookhianestezi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Yousef Kolookhi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahrood, University of Blvd., Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3239 0077
Email
dryousefkolookhianestezi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aboutaleb Safdari
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahrood, University of Blvd., Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3239 0077
Email
aboutaleb.safdari@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Given the importance of protecting the privacy of patients if they hide patient information and merely inform potential cases
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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