Evaluation of the effects of Three Methods of Tranexamic Acid Administration on post operative blood loss following total knee arthroplasty compared with the control group
Determination of the effects of Three Methods of Tranexamic Acid Administration on post operative blood loss following total knee arthroplasty compared with the control group
Design
A randomized, double-blinded, controlled trial design of 200 patients
Settings and conduct
Between Sep 2019 and March 2020, patients who is scheduled to undergo a unilateral total knee arthroplasty in two educational hospitals of Kerman University of Medical Sciences will be enrolled in the study.
Neither the patient nor the physician who assessed the results knew the patient’s study group.
Participants/Inclusion and exclusion criteria
200 patients who scheduled to undergo a unilateral primary TKA
were enrolled in the study who all gave their written informed consent for participation in the study. The exclusion criteria were the patients with cardiovascular diseases including myocardial infarction, atrial fibrillation and angina; Cerebrovascular diseases and history of thromboembolic disease, bleeding disorder, known allergy to tranexamic acid, and receiving the anti-coagulant drugs.
Intervention groups
Patients in group 1, received 10 mg/kg intravenous tranexamic acid in 100cc saline; immediately after the wound closure. In patients in group 2, knee joint with 3 g of tranexamic acid in 100 cc saline was washed before the closure of the wound for 5 minutes. In patients in group 3, immediately after the closure of the wound, 1.5 grams of tranexamic acid in 100cc saline will be injected into the knee joint through the drainage. Group 4 (control group) is not treated with tranexamic acid, and the drain is only clamped for one hour and then opened. In all groups, only one drain is inserted deeply into the knee joint, and clamped for an hour and then completely opened and released after 48 hours.
Main outcome variables
The amount of hemoglobin, post-operative total blood loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160105025871N2
Registration date:2019-10-19, 1398/07/27
Registration timing:registered_while_recruiting
Last update:2019-10-19, 1398/07/27
Update count:0
Registration date
2019-10-19, 1398/07/27
Registrant information
Name
Pardis Sasani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8855 0680
Email address
p_sasani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Three Methods of Tranexamic Acid Administration on post operative blood loss following total knee arthroplasty compared with the control group
Public title
Comparison of different methods of tranexamic acid administration on post operative blood loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who scheduled to undergo a unilateral total knee arthroplasty
Exclusion criteria:
Cardiovascular diseases
Cerebrovascular diseases
Bleeding disorders
Known allergy to tranexamic acid
Receiving the anti-coagulant drugs
History of thromboembolic disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-generated list was created by the blocks of 12 randomization method
Blinding (investigator's opinion)
Double blinded
Blinding description
The concealed envelopes were used to blind the surgeon and participants
for the randomization sequences and opened by a orthopedic resident, who was not involved in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
kerman
Province
Kerman
Postal code
7616913911
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.KMU.REC.1397.245
Health conditions studied
1
Description of health condition studied
Amount of bleeding following total knee arthroplasty
ICD-10 code
Z96.659
ICD-10 code description
Presence of unspecified artificial knee joint
Primary outcomes
1
Description
The amount of hemoglobin
Timepoint
Preoperatively, 24 hours postoperatively and in the morning discharge day
Method of measurement
Complete Blood Count (CBC) test
2
Description
Post-operative drained blood volume
Timepoint
48 hours after the operation
Method of measurement
Hemovac drain
Secondary outcomes
1
Description
Surgical site infection
Timepoint
48 hours postoperatively
Method of measurement
clinical examination
Intervention groups
1
Description
Intervention group: 10 mg/kg of intravenous tranexamic acid in 100 cc of normal saline will be administrated following wound closure. The drain will be clamped for an hour.
Category
Treatment - Drugs
2
Description
Intervention group: The articular space will be irrigated with 3 gr of tranexamic acid for 5 minutes before knee closure. The drain will be clamped for an hour.
Category
Treatment - Drugs
3
Description
Intervention group: 1.5 gr of tranexamic acid will be delivered to the knee via the drain following wound closure. The drain will be clamped for an hour.
Category
Treatment - Drugs
4
Description
Control group: The drain will be clamped for an hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital, Shafa Hospital
Full name of responsible person
Behnam Behmardi Kalantari
Street address
Bahonar Hospital, Qaraney St.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3212 2405
Email
pardis_sasani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Ebne Sina St., Somayeh Intersection, Deputy of research and technology
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Behnam Behmardi Kalantari
Position
Orthopedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Bahonar Hospital, Qaraney St
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3212 2405
Email
pardis_sasani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Behnam Behmardi Kalantari
Position
Orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Bahonar Hospital, Qaraney St.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3252 2405
Email
pardis_sasani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Behnam Behmardi Kalantari
Position
Orthopedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Bahonar Hospital, Qaraney St
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3212 2405
Email
pardis_sasani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available