Comparison of the effects of Rivaroxaban and Enoxaparin on the reduction of venous thromboembolism after spinal surgery
Design
A phase 3 Randomized clinical trial, with parallel group designed for 250 patients
Settings and conduct
Patients who underwent spine surgery at Imam Hossein Hospital in Tehran were included in the study to evaluate the effects of rivaroxaban and enoxaparin on reducing post operation deep vein thrombosis and venous embolism. All patients were evaluated after surgery for DVT and PTE by venous Doppler ultrasound and CT angiography of the lungs.
Participants/Inclusion and exclusion criteria
Patients who have undergone spine surgery and have no previous history of venous thromboembolism or cerebrovascular accident.
Intervention groups
Patients after spine surgery were divided into 3 groups, the group receiving Rivaroxaban, the group receiving Enoxaparin and the control group.
Main outcome variables
Deep vein thrombosis; Pulmonary thromboembolism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200808048333N1
Registration date:2021-10-29, 1400/08/07
Registration timing:retrospective
Last update:2021-10-29, 1400/08/07
Update count:1
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Poorya Paryan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
pooryaparyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Rivaroxaban and Enoxaparin on preventing the venous thromboembolism after spinal surgery
Public title
Comparison of Rivaroxaban and Enoxaparin for preventing venous thromboembolism after spine surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing spine surgery
No previous history of thromboembolism
Exclusion criteria:
Previous history of venous thromboembolism
Pregnancy
History of cerebrovascular accident
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients with simple sampling method, they were numbered first and then were divided into different groups based on a table of random numbers.
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 Shahid Beheshti University of Medical Sciences
Street address
Imam Hosein Hospital,Madani Ave
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.SBMU.MSP.REC.1399.411
Health conditions studied
1
Description of health condition studied
Deep Venous Thrombosis And Pulmonary Eembolism
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
At the begining of the study,14 days after
Method of measurement
Color Doppler Ultrasonography of the lower Extremities
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipient of Rivaroxaban, patients that receive Rivaroxaban (10mg orally) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated.
Category
Treatment - Drugs
2
Description
Intervention group: Recipient of Enoxaparin, patients that recieve Enoxaparin (40 mg subcutaneous ) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated.