According to problems of bleeding in knee Arthroplasty surgery patients, the aim of this study is to determine the effect of local injection of transamic acid compare to into drain injection in arthroplasty patients.
In this study , 75 patients will be selected randomly. Inclusion criteria : 18-85 years old patients who have arthroplasty surgery exclusion criteria : patients who have secondary osteoarthritis like rheumatoid arthritis and arthritis following by trauma and gout and arthritis following by joint infection.
Patients will be divided in 3 groups by random. First group will get placebo in their clamped drain, in second group trabsamic acid will be injected in their clamped drain and the third group will get transamic acid as local injection. All the surgeries will be done by one specialist surgeon. Patients, surgeon and data collectors will be blinded. Hemoglobin will be measured before and 12-8-4 hours after surgery and according to above protocol , a decisions was made. All patients will be releasing 5 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122730123N1
Registration date:2016-12-27, 1395/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Ehsan Golkar Khozani
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 6389
Email address
e.golkar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of medical Sciences accepted to supply drug for this study
Expected recruitment start date
2016-11-16, 1395/08/26
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of topical tranexamic acid compare to injection into the clamp drain on the bleeding after knee arthroplasty surgery
Public title
The effectiveness of topical tranexamic acid compare to injection into the clamp drain on the bleeding after knee arthroplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Adults age between 18- 85 years; patients who need artheroplasty
Exclusion criteria: Secondary artheritis like rheumatoid artheritis; traumatic artheritis; gout; infectious artheritis ; patients with chronic disease (ischemic cardiopathy, nocturnal apnea syndrome, severe pulmonary disease, chronic renal failure, liver failure, and ...; History of thromboembolic disease (platelet under 150000 in milimiter, INR upper 1.4, and PTT 1.4 upper than normal ratio; hemorrhagic disease; allergy to tranxamic acid; anticoagulant drug users
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahid Sadoughi Faculty of Medicine, Yazd
Street address
Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam blv, Professor Hesabi blv,Yazd
City
Yazd
Postal code
Approval date
2016-05-01, 1395/02/12
Ethics committee reference number
ir.ssu.medicine.rec.1395.17
Health conditions studied
1
Description of health condition studied
Arthrosis of Knee
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Hemoglobin level of blood
Timepoint
12 and 48 hour after surgery
Method of measurement
Grams of hemoglobin per deciliter blood with full automatic laboraty devices
Secondary outcomes
1
Description
Deep vein thrombosis
Timepoint
During the hospitalization of patients and during post operational follow up of pateints
Method of measurement
Physical examination and medical history of pateint
Intervention groups
1
Description
Control: 30 ml of normal saline will use in drain and drain will be clamp
Category
Treatment - Drugs
2
Description
Intervention1: 15 mg tranexamic acid before closure of the wound and 15 mg tranexamic acid after closure of skin will use
Category
Treatment - Drugs
3
Description
Intervention2: 30 ml normal saline with 3mg tranexamic acid will use for 3 hour after clamp of drain.