Comparison of Dabigatran and Enoxaparin in prophylaxy of Thromboembolic events in patient with total knee replacement surgery in Shariati hospital in 1392
This is a clinical trial on 90 patients who are candidate for TKR.Patients divided to two equal group.Venous theromboemboli(VTE)will carry out in first group by subcutaneous enoxaparin(40 mg)12 hours before surgery and then every day up to 15 days;and in second group by dabigatran 150 mg stat and 225 mg per day up to 15 days.in this 15 days period patients will monitored of bleeding or VTE events.then sonodoppler of lower limbs will perform for all of them.and follow-up of bleeding will continue up to 3 months .at the end all findings will be recorded and analyzed by SPSS soft ware.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082513828N2
Registration date:2013-10-08, 1392/07/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-08, 1392/07/16
Registrant information
Name
Ahmad Mirdamadi
Name of organization / entity
Islamic Azad university ,Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 8028
Email address
drsamirdamadi@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University,Najafabad branch,Isfahan
Shariati Hospital
Expected recruitment start date
2013-08-12, 1392/05/21
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dabigatran and Enoxaparin in prophylaxy of Thromboembolic events in patient with total knee replacement surgery in Shariati hospital in 1392
Public title
Comparison of Dabigatran and Enoxaparin in prophylaxy of Thromboembolic events
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Patients who are candidate for total knee replacement(TKR)in shariati hospital
Age more than 18 years
patient's content
Exclusion criteria:History of:
Bleeding disorder, Recent stroke, Major surgery,trauma,Myocardial
infarction,Uncontrolled Hypertension in recent 3 months,Liver or GI disease,GI or
GU bleeding in recent 6 months,Use of NSAIDs in recent week,active malignancy,
Thrombocytopnia,Contrast over sensitivity,Renal failure
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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
1
Registry name
Nbr121456
Secondary trial Id
556783
Registration date
2011-02-07, 1389/11/18
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2013-08-12, 1392/05/21
Ethics committee reference number
492016
Health conditions studied
1
Description of health condition studied
Thromboembolic Disease
ICD-10 code
180-189
ICD-10 code description
198
Primary outcomes
1
Description
Deep Vein Thrombophelebitis of Legs
Timepoint
15 days after surgery
Method of measurement
Sonodoppler of Legs' Veins
Secondary outcomes
1
Description
Bleeding
Timepoint
Every day up to 15 days and then up 3 months
Method of measurement
Physical Exam
Intervention groups
1
Description
Dabigatran group: Dabigatran 150 mg stat and 225 mg per day up to 15 days will be prescribed .
Category
Treatment - Drugs
2
Description
Enoxaparin group:subcutaneous enoxaparin(40 mg)12 hours before surgery and then 40 mg every day up to 15 days will be carrird out