Comparison of the Effect of Rivaroxaban and Enoxaparin in Coagulation Setting for Lower Limb Fracture Surgerys to Prevent Deep Vein Thrombosis and Pulmonary Embolism
The Effect of Rivaroxaban and Enoxaparin in Coagulation Setting for Lower Limb Fracture Surgerys to Prevent Deep Vein Thrombosis and Pulmonary Embolism
Design
Clinical Trial with Control Group, with a parallel group design of 50 patients، Randomized by Cards, Phase:3
Settings and conduct
The Study was Performed in Sabzevar Shahid Beheshti Emdadi Hospital,The Study is done Double Blindly and is done by Cards that the Person who is Allocating it is not aware of its Content. Color Doppler Ultrasound Results are Performed by a Physician who is unaware of the Type of Treatment Assigned. to Blind the Patients, Patients Receiving Enoxaparin are also given Folic Acid Tablet, and Patients Receiving Rivaroxaban are given Distilled Water Injections.
Participants/Inclusion and exclusion criteria
Entry Requirements:All People over the Age of 20 Years who are Candidates for Anticoagulant Therapy
Conditions for Denial of Entry:
History of Hypersensitivity Reaction to either of the Two Drugs ,Severe Bleeding, Pregnancy and Lactation, History of Recent Labor or any Recent Injury, Having Liver Disease or any other Disease that Leads to an Increased Risk of Bleeding.
Intervention groups
Intervention group: People who receive oral Rivaroxaban 10mg Daily for 12 Days and at the same time distilled water were injected into those.
Control group: People who receive Enoxaparin Subcutaneous 40mg Daily for 10 Days and at the same folic acid tablet was taken daily into those.
Main outcome variables
Deep Vein Thrombosis;Pulmonary Embolism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041781N1
Registration date:2019-10-14, 1398/07/22
Registration timing:retrospective
Last update:2019-10-14, 1398/07/22
Update count:0
Registration date
2019-10-14, 1398/07/22
Registrant information
Name
Salar Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4623 4685
Email address
abdis91@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-07, 1397/11/18
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Rivaroxaban and Enoxaparin in Coagulation Setting for Lower Limb Fracture Surgerys to Prevent Deep Vein Thrombosis and Pulmonary Embolism
Public title
Effect of Rivrvoxaban on the Prevention of Deep Vein Thrombosis and Pulmonary Embolism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All People over the Age of 20 Years who are Candidates for Anticoagulant Therapy
Exclusion criteria:
History of Hypersensitivity Reaction to either of the Two Drugs
Severe Bleeding
Pregnancy and Lactation
History of Recent Labor or any Recent Injury
Having Liver Disease or any other Disease that Leads to an Increased Risk of Bleeding.
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The Allocation of Treatment is done Randomly by Cards. Individual Randomization Unit.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Allocation of Treatment is done Randomly(The Permutation Block Method that Blinds Donors to Treatment) and by Cards that the Person who is Allocating it is not Aware of its Content.The Results of Color Doppler Ultrasound are not known from the type of Treatment Prescribed, which Includes Enoxaparin 40 mg Subcutaneous Daily and Rivaroxaba 10 mg Daily Oral.The Person Who Cares for the Clinic is also not Aware of the Contents of the Cards. The Examination of the Entended outcome Include Deep Vein Thrombosis or Pulmonary Embolism after Surgery, Which is Evaluated one Month after Starting Treatment and Observation of the Symptoms of Deep Venous Thrombosis (Warmth, Pain, Swelling, Especially the Back of the Leg) and Pulmonary Embolism (Dyspnea, Pleuretic Pain, Orthopnea), The Ultrasound Results are not known by the Medical Specialist who is Assigned the Type of Treatment. In Order to Bblind the Evaluator of Treatment, an Attempt was made to use a Separate Individual from the Therapist (who is Medical Student in this Study). to Blind the Patients, Patients Receiving Enoxaparin are also given Folic Acid Tablet, and Patients Receiving Rivaroxaban are given Distilled Water Injections.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Campus of the University of Medical Sciences, Above the Shohadaye Gomnam, Shohadaye Hastei Blvd.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.MEDSAB.REC.1397.076
Health conditions studied
1
Description of health condition studied
Deep Vein Thrombosis
ICD-10 code
I80.2
ICD-10 code description
Phlebitis and thrombophlebitis of other deep vessels of lower extremities Deep vein thrombosis
2
Description of health condition studied
Pulmonary Embolism
ICD-10 code
i26
ICD-10 code description
Pulmonary embolism
Primary outcomes
1
Description
Deep Vein Thrombosis
Timepoint
One Month after Receiving Treatment
Method of measurement
Examinations and Color Doppler Ultrasound
2
Description
Pulmonary Embolism
Timepoint
One Month after Receiving Treatment.
Method of measurement
Examinations and Color Doppler Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People who receive oral Rivaroxaban 10mg Daily for 12 Days then at the same time, distilled water were injected to those
Category
Prevention
2
Description
Control group: People who receive Enoxaparin Subcutaneous 40mg for 10 Days then at the same time, a folic acid tablet daily was taken to those
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Emdad Hospital
Full name of responsible person
salar abdi
Street address
Razi street, Shahid Beheshti Emdad Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617748189
Phone
+98 51 4464 0115
Email
salar.abdi.1371@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte Ghorat
Street address
Campus of the University of Medical Sciences, Above the Shohadaye Gomnam, Shohadaye Hastei Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Phone
+98 51 4401 8319
Fax
+98 51 4401 8319
Email
Drghorat@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
salar abdi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Razi street, Shahid Beheshti Emdad Hospita
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618614341
Phone
+98 51 4464 0115
Email
salar.abdi.1371@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
salar abdi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Razi street, Shahid Beheshti Emdad Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618614341
Phone
+98 51 4464 0115
Email
salar.abdi.1371@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Salar Abdi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Andisheh building ، Sabzevar Medical Sciences Hostel ، 5 km of Sabzevar Tehran Road
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 5555 6070
Email
Salar.Abdi.1371@gmail.com
Web page address
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