In this study we are aiming to investigate the effect of the antioxidant agent including ascorbic acid on the amount of hidden blood loss in total knee arthroplasty (TKA).
Design
A double-blind randomized controlled trial with two parallel groups
Settings and conduct
In this randomized controlled clinical trial, 100 patients which are scheduled for TKA will be consecutively assigned into two groups in a 1:1 ratio. The patients in group A will receive three doses of ascorbic acid. The patients in group B will receive only normal saline as a control group. In this double-blind study, patients and data collectors are blinded and unaware of the patient's assigned group. Informed consent will be obtained from all the patients prior to the surgery.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients who are scheduled for total knee arthroplasty. Non-inclusion criteria: history of thromboembolic events like deep vein thrombosis or pulmonary embolism; a history of cardiovascular disease; clotting disorders including abnormal PT, PTT or INR; being in pregnancy or in the lactation period; drug abusers or alcoholics; severe renal dysfunction; severe infection; the preoperative hemoglobin <10 g/dL; diagnosis of inflammatory arthritis
Intervention groups
Intervention group: patients in this group will receive the first ascorbic acid dose (1 g in 10 mL) at the beginning of the surgery. Another dose of ascorbic acid (1 g in 10 mL) will be infused during the surgery. After the surgery, an additional dose of ascorbic acid (1 g in 10 mL) will be infused during the first 12 hour postoperative period. Control group: The patients in this group will receive only normal saline.
Main outcome variables
Total blood loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221104056393N1
Registration date:2023-06-27, 1402/04/06
Registration timing:registered_while_recruiting
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Pooya Hosseini-Monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 1072
Email address
pomonfared@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-18, 1402/03/28
Expected recruitment end date
2023-06-29, 1402/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Ascorbic Acid compared to normal saline on the hidden blood loss in total knee arthroplasty
Public title
The Effect of Ascorbic Acid on the blood loss in Total Knee Arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates of total knee arthroplasty
patients who provide written informed consent to be included in this study
Exclusion criteria:
history of thromboembolic events like deep vein thrombosis or pulmonary embolism
history of cardiovascular disease like myocardial infarction or atrial fibrillation
being in pregnancy or in the lactation period
drug abusers or alcoholics
severe renal dysfunction
severe infection
the preoperative hemoglobin less than 10 g/dL
diagnosis of inflammatory arthritis like rheumatoid arthritis, pigmented villonodular synovitis and etc
clotting disorders including abnormal PT, PTT or INR
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized controlled clinical trial, the patients will be consecutively and alternately (one in between) assigned into two groups in a 1:1 ratio.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients and the data collector are blinded. Patients are kept unaware of their group assignment and the intervention they are receiving. Patients in both groups receive serums with covers so that the content will not be visible to the patients. Both the treatment and control groups receive identical instructions and support. The data collector is kept blind to the group assignment of each patient. Collecting data including laboratory values after the surgery and clinical examinations will be performed without knowing the intervention done for the patient and only according to their records number.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Azar dead end alley, Sharifi Manesh street., Pole Roomi, Tajrish
City
Tehran
Province
Tehran
Postal code
1964714953
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.165
Health conditions studied
1
Description of health condition studied
Total Knee Arthroplasty
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified
Primary outcomes
1
Description
total blood loss
Timepoint
Before intervention, 24h after intervention
Method of measurement
amount of Hemoglobin drop
Secondary outcomes
1
Description
Transfusion rate
Timepoint
Before the intervention, 24h after the intervention
Method of measurement
number of units of blood transfused
Intervention groups
1
Description
Control group: The patients in the control group will receive only normal saline.
Category
Treatment - Surgery
2
Description
Intervention group: The patients in the intervention group will receive the first ascorbic acid dose (1 g in 10 mL) at the beginning of the surgery. Another dose of ascorbic acid (1 g in 10 mL) will be infused during the surgery. After the surgery, an additional dose of ascorbic acid (1 g in 10 mL) will be infused postoperatively during the first 12h.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Seyed Morteza Kazemi
Street address
Azar dead end alley, Sharifi Manesh St., Pole Roomi, Tajrish
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
pomonfared@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Azar dead end alley, Sharifi Manesh St., Pole Roomi, Tajrish
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
boneresearch@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Morteza Kazemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Azar dead end alley , Sharifi Manesh street, Pole Roomi, Tajrish
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
kazemimort@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Morteza Kazemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Azar dead end alley , Sharifi Manesh street, Pole Roomi, Tajrish
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
kazemimort@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pooya Hosseini-Monfared
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
Orthopedics
Street address
Azar dead end alley , Sharifi Manesh street, Pole Roomi, Tajrish
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
pomonfared@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared after making the individuals undetectable.
When the data will become available and for how long
Access will be granted 6 months after the results of the study are published.
To whom data/document is available
Researchers and medical specialist
Under which criteria data/document could be used
based on the Ministry of Health and Medical Education criteria for clinical trials
From where data/document is obtainable
Orthopedic department of Shahid Beheshti Medical University
What processes are involved for a request to access data/document
The data will be provided after reviewing the researcher's request and providing sufficient documentation of their research and the reason for using the data.