Comparative study of intra-articular and intravenous tranexamic acid effects on lowering postoperative blood loss in TKA patients in Imam Khomeini Hospital whit aspirin as a VTE prophylaxis and no uses of close suction drain.
Design
In this prospective randomized clinical trial, TKA patients randomly allocated to two equal groups with IA and IV TXA injection.
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
TKA patients who were operated in Imam Khomeini Hospital from July 2017 to February 2018 without any history of cardiovascular, Bleeding and thrombosis diseases.
Intervention groups
49 TKA patients were intravenously given 15 mg/kg dose of TXA and 49 patients intraarticularly received 15 mg/kg of TXA
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
TXA
IRCT registration information
IRCT registration number:IRCT20160809029286N3
Registration date:2019-02-02, 1397/11/13
Registration timing:retrospective
Last update:2019-02-02, 1397/11/13
Update count:0
Registration date
2019-02-02, 1397/11/13
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
2017-07-23, 1396/05/01
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-03-20, 1396/12/29
Scientific title
Intra-articular versus Intravenous Tranexamic Acid in total knee arthroplasty patients in Imam Khomeini Hospital 2017-2018
Public title
Intra-articular versus Intravenous 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
Care provider
Sample size
Target sample size:
98
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
The TKA candidate Patients randomly allocated to IA and IV TXA groups as a blind randomized clinical trial
Blinding (investigator's opinion)
Double blinded
Blinding description
During the injection of tranexamic acid, the person who do the injection hadn't any information of 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
Imam Khomeini Hospital, End of Keshavarz blvd, Keshavarz Blvd, Tehran