Protocol summary

Study aim
Comparison the effect of intra-articular and intravenous and combine IA & IV tranexamic acid on lowering postoperative blood loss in TKA patients with aspirin as a VTE prophylaxis and no uses of close suction drain.
Design
In this prospective randomized clinical trial, TKA patients randomly allocated to three equal groups with IA, IV and combine IVIA TXA injection. The study was parallel and double blinded which the patients and assessor were blinded from the study. Randomization was performed by the permuted balanced blocks method for all the patients.
Settings and conduct
A prospective randomized clinical trial study ran in imam Khomeini hospital from July 2017 to February 2018
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients who underwent TKA surgery in Imam Khomeini Hospital Exclusion Criteria: Any history of cardiovascular, Bleeding and thrombosis diseases. Revision TKA surgery
Intervention groups
49 TKA patients were intravenously (IV) given 15 mg/kg dose of TXA, 49 patients intraarticularly (IA) received 15 mg/kg of TXA and 49 patents received both IV and IA injection 15 mg/kg in each method
Main outcome variables
Demographic information, pre-operative and post-operative hemoglobin values of the patients were used for assessing total perioperative blood loss by GOOD & NADLER formulae.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160809029286N6
Registration date: 2020-04-29, 1399/02/10
Registration timing: retrospective

Last update: 2020-04-29, 1399/02/10
Update count: 0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Alireza Moharrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 7418
Email address
a-moharrami@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
1917-07-23, 1296/05/01
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-03-20, 1396/12/29
Scientific title
Intra-articular vs Intravenous vs combine IVIA Tranexamic Acid in total knee arthroplasty patients
Public title
Intra-articular vs Intravenous vs combine IVIA Tranexamic Acid in total knee arthroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Total knee arthroplasty candidate patients Surgery in Imam Khomeini Hospital Not having a specific bleeding disorder Not having any co-morbidity Not having any cardiovascular diseases Accept the terms of participation in the study voluntarily
Exclusion criteria:
Cardiovascular diseases Any co-morbidity Any bleeding disorders Thromboembolie and stroke history Not voluntary Sensitivity to tranexamic acid Revision TKA
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 147
Actual sample size reached: 147
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted balanced blocks method was used. In this method, six balanced blocks (1 to 6) were defined regarding the three interventions of the study (A, B, C) including BAC, ACB, ABC, CAB, BCA and CBA . The patients were divided into 49 groups of three patients. The patients’ numbers were inserted from 1 to 147 in a column using MS Excel software. In another column, the group of each patient was inserted, for example: patients 1 to 3 as group 1, patients 4 to 6 as group 2, …, patients 144 to 147 as group 49. In another Excel sheath, the groups were inserted from 1 to 49, and the blocks were inserted across each group from 1 to 6 in order till the end. In the next column, non-repeated random numbers were inserted using the “RANDL()” command. Subsequently, the order of the blocks was randomly changed. According to the block assigned with each group, the intervention regarding each patient was determined. For example, if group 1 is assigned with “CAB”, the interventions were as follows: Patient 1, C; Patient 2, A; Patient 3, B.
Blinding (investigator's opinion)
Double blinded
Blinding description
During the injection of tranexamic acid, the person who does the injection hadn't any information about the study. Patients are not aware of the medication model of injection. Patients are divided into groups by random code designed by the researcher and identified with the patient ID at the time of analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
mam Khomeini Hospital, End of Keshavarz blvd, Keshavarz Blvd, Tehran
City
tehran
Province
Tehran
Postal code
1419733141
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2879

Health conditions studied

1

Description of health condition studied
Blood Loss after Total Knee Arthroplasty
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Post-operative Hb to pre-operative Hb
Timepoint
Pre-operative, 24 hour post-operative, 48 hour post-operative, 72 hour post-operative
Method of measurement
With blood lab test and blood loss calculation with GOOD & NADLER formulae

Secondary outcomes

1

Description
Occurrence of vascular thrombosis, DVT, Stroke and embolism
Timepoint
At least two years Follow-up
Method of measurement
Physical exam and para-clinics

Intervention groups

1

Description
Intervention group: 15 mg/kg TXA intra-Articular injection post-operative
Category
Treatment - Drugs

2

Description
Intervention group: 15 mg/kg TXA intravenous injection before the surgery and performing tourniquet
Category
Treatment - Drugs

3

Description
Intervention group: TXA was injected in combination of postoperative intra-Articular and preoperative intravenous methods and 15 mg/kg for each method
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Complex Hospital
Full name of responsible person
Dr Seyed Mohammad Javad Mortazavi
Street address
Imam Khomeini Hospital, End of Keshavarza Blvd, Tehran, IRAN
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
Http://ikhc.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Joint Reconstruction Research Center
Full name of responsible person
Dr Seyed Mohammad Javad Mortazavi
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
Http://www.ikch.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Joint Reconstruction Research Center
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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Moharrami
Position
Orthopaedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran , IRAN
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2767
Email
a-moharrami@student.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Javad Mortazavi
Position
Hip and Knee surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6653 1354
Email
smjmort@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Moharrami
Position
Orthopaedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran, IRAN
City
tehran
Province
Tehran
Postal code
1955743849
Phone
+98 21 6119 0000
Email
a-moharrami@student.tums.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
En At the end of the study, All data Except Demographics will be published.
When the data will become available and for how long
July 2020
To whom data/document is available
Orthopedic Surgeons
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Anyone can request study data by sending an email to the plan executor (َAlireza Moharrami).
What processes are involved for a request to access data/document
Within 2 weeks will be answered
Comments
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