Comparison the Injectual Enoxaparin with Oral Rivaroxaban in DVT Prophylaxis of Patients with Pre-Trochanteric Hip Fracture.
Design
The clinical trial included a control and parallel group that would not be blind to any subjects after random assignment.
Settings and conduct
No one is blind to this study. Eighty patients in need of hip surgery will receive the intervention and receive either one of the two drugs rivaroxaban or enoxaparin.
In this clinical trial study, 80 patients will be enrolled in the study and after randomized assignment, will receive the appropriate intervention (receiving rivaroxaban or enoxaparin). Intervention will be performed at Shohada hospital in Tabriz.
Main outcome variables
Deep vein thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N16
Registration date:2019-12-22, 1398/10/01
Registration timing:prospective
Last update:2019-12-22, 1398/10/01
Update count:0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Injectual Enoxaparin with Oral Rivaroxaban in DVT Prophylaxis of Patients with Pre-Trochanteric Hip Fracture
Public title
Prevention of deep vein thrombosis in pre-trochanteric hip fracture
All patients will be randomly assigned to one of the two groups of enoxaparin or rivaroxaban with the help of an online randomization list (www.randomizer.org).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.TBZMED.REC.1398.969
Health conditions studied
1
Description of health condition studied
Deep vein thrombosis
ICD-10 code
I82.4
ICD-10 code description
Acute embolism and thrombosis of deep veins of lower extremity
Primary outcomes
1
Description
Deep vein thrombosis
Timepoint
Once before the intervention and once at the end of the study (30 days later)
Method of measurement
Take a blood test and check the level of D-Dimer in the blood
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group, after surgery, they will receive 40 mg of enoxaparin subcutaneously for 30 days (one daily). The enoxaparin ampoule will be purchased from Iran Daroo Company ready and given by a nurse every day. Blood will be taken from the patient before the intervention and on the last day of the intervention and serum D-Dimer levels will be measured.
Category
Prevention
2
Description
Control group: patients will be enrolled after random assignment. In the intervention group, after surgery, 10 mg rivaroxaban will be given orally for 30 days (one daily). Rivaroxaban tablets will be purchased from Iran Daroo Company and will be administered daily by a nurse. Blood will be taken from the patient before the intervention and on the last day of the intervention and serum D-Dimer levels will be measured.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Mosayeb Hoseinzadeh
Street address
Azadi Ave, Shohada Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
m88hosseinzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bazavar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Mbazavar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bazavar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Mbazavar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available