Some studies have been shown that administration of tranexamic acid during knee arthroplasty in patients without history of thromboembolic events decreases the bleeding and transfusion and also decreases the numbers of units transfused after surgery. In this double blind clinical trial study, 54 patients with knee arthroplasty are divided randomely in two groups including intervention and control group. We will only prescribe oral tranexamic acid to the first group before surgery but we will not prescribe anything for the control group. We will measure bleeding rate after 12 and 24 hour of surgery in the 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009204780N1
Registration date:2012-02-04, 1390/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-04, 1390/11/15
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
alipourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Mashhad University of Medical Sciences
Expected recruitment start date
2012-01-31, 1390/11/11
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of oral tranexamic acid administration on blood loss after knee artroplasty
Public title
Effect of tranexamic acid on blood loss after knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adults’ patients undergoing knee artheroplasty.
Exclusion criteria: patients with history of ischemic heart diseases, renal failure, cirrhosis, bleeding disorders and consumption of NSAID or anticoagulants.
Age
From 20 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of medical sciences
Street address
Research vice chancellor of Mashhad University of Medical Sciences, Daneshgah st.
City
Mashhad
Postal code
Approval date
2009-12-30, 1388/10/09
Ethics committee reference number
88483
Health conditions studied
1
Description of health condition studied
knee artherosis
ICD-10 code
M15-M19
ICD-10 code description
Arthrosis
Primary outcomes
1
Description
bleeding
Timepoint
12 and 24 hours after surgery
Method of measurement
bleeding in drain in milliliters
Secondary outcomes
empty
Intervention groups
1
Description
control: without a drug or placebo prescription
Category
N/A
2
Description
intervention: Prescription of oral tranexamic acid two hours before surgery and every 6 hours until 18 hours after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor of Mashhad University of medical sciences
Full name of responsible person
Dr. Tvakol Afshar
Street address
Research vice chancellor, Ghoreishy building, University street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor of Mashhad University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
Azam Moradi Zarmehri
Position
resident of anesthesiology
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1881 8229
Fax
Email
moradia872@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
Mohammad Ali Alipour
Position
anesthesiologist
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
alipourm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Azam Moradi Zarmehri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)