Comparison of Enoxaparin versus oral Rivaroxaban in prevention of deep vein thrombosis in patients admitted to intensive care unit
Design
This study is clinical trial and single blind.98 patients in ICU in Valiasr Hospital in Arak will inter this study.We will divide patients in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and single blind.98 patients will inter this study.Outcome assessor and analyzer don't aware from grouping.Groups A and B are available to analyzer and outcome assessor.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Ages 18 to 60 years, gavage or beginning of oral feeding, glomerular filtration above 50%
Exclusion criteria:contraindications to anti-coagulant, allergy to Rivaroxaban
Intervention groups
Intervention group: We treat patients with 15 milligram Rivaroxaban tablets once in day orally or gavage until they have the order to get out of bed.
Control group:We treat patients with 40 milligram Enoxaparin once day subcutaneously until they have the order to get out of bed.
Main outcome variables
Incidence of thromboembolism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N140
Registration date:2020-04-08, 1399/01/20
Registration timing:retrospective
Last update:2020-04-08, 1399/01/20
Update count:0
Registration date
2020-04-08, 1399/01/20
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Enoxaparin versus oral Rivaroxaban in prevention of deep vein thrombosis in patients admitted to intensive care unit
Public title
Comparison of two kind of drug oral and subcutaneous in prevention of deep vein thrombosis in patients admitted to intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 60 years
Possibility to gavage or start oral feeding
Glomerular filtration above 50%
Patients hospitalized in intensive care units
Exclusion criteria:
Contraindications to anti-coagulant
Allergy to Rivaroxaban
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization will be used with envelopes in two groups A and B.
In this method, we will select a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards will be shuffled. One card will be taken out and its allocation is registered and the card was returned to the other cards after leaving. Then the cards are shuffled again and we will take another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-10-21, 1397/07/29
Ethics committee reference number
IR.ARAKMU.REC.1397.189
Health conditions studied
1
Description of health condition studied
Thromboembolism
ICD-10 code
O88.23
ICD-10 code description
Embolism and thrombosis of unspecified artery
Primary outcomes
1
Description
Incidence of thromboembolism
Timepoint
After the end of treatment
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We treat patients with 15 milligram Rivaroxaban tablets daily orally or oral gavage until they have the order to get out of bed.
Category
Treatment - Drugs
2
Description
Control group: We treat patients with 40 milligram Enoxaparin ampule daily subcutaneously until they have the order to get out of bed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street