Comparison of the efficacy of oral, intravenous and topical tranexamic acid in reducing bleeding after total knee arthroplasty
Design
This study is clinical trial and double blind. 135 patients candidate arthroplasty referring to Amiralmomenin hospital and Vali Asr hospital in Arak will enter this study. We will divide patients in 3 groups randomly.
Settings and conduct
This study is clinical trial and double blind. 135 patients candidate arthroplasty referring to Amiralmomenin hospital and Vali Asr hospital in Arak will enter this study.Patients and outcome reviewer and analyzers are unaware of grouping. The study is double-blinded.
Participants/Inclusion and exclusion criteria
Patients undergoing total knee arthroplasty coming to Amiralmoemenin and Valiasr hospital in Arak; Patients between 30 and 80 years old; Patient with ASA class1 & ASA class2; Patients who have informed consent for presence in mentioned project; Patients who are operated by one surgeon; Operation time between 90 and 180 minutes
Intervention groups
We prescribe 10 milligram in kilogram Tranexamic acid by slow intravenous injection in first group.We prescribe 2 gram Tranexamic acid in 1000 milliliter normal salin by intra-articular in second group.We prescribe 1 gram Tranexamic acid oral and one dose in operation room in third group.
Main outcome variables
Mean of hemorrhage in postoperative; mean of hemorrhage during operation; return of patients with arthroplasty candidate to the operating room;
mean of hemoglobin in postoperative
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180411039272N1
Registration date:2018-06-10, 1397/03/20
Registration timing:registered_while_recruiting
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-23, 1397/02/03
Expected recruitment end date
2019-06-24, 1398/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oral, intravenous and topical Tranexamic acid in reducing bleeding after total knee arthroplasty
Public title
Comparison of the efficacy of oral, intravenous and topical Tranexamic acid in reducing bleeding after total knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing total knee arthroplasty admitted in Amiralmoemenin and Valiasr hospital in Arak
Patients between 30 and 80 years old
Patient with ASA class1 and 2
Patients who have informed consent for presence in mentioned project
Patients who are operated by one surgeon
duration of operation time between 90 and 180 minutes
Exclusion criteria:
All Patients out rang of 30 to 80 years old
Lack of Informed consent
Patients with multiple surgeries
Patients who are sensitive to Tranexamic acid
Patients undergoing general anesthesia
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number tables
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and outcome reviewer and analyzers are unaware of grouping. The study is double-blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Arak university of medical sciences