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General information
Not blinded
Triple blinded
notbltripl
1
1
1
1
1
1
1
1
1
1
1
1
250
200
250200
empty
220
220
empty
2020-08-22, 1399/06/01
2020-08-22 00:00:00
empty
2022-12-13, 1401/09/22
2022-12-13 00:00:00
empty
Supplementary data from the clinical trial was recorded
Supplementary data from the clinical trial was recorded
empty
داده های تکمیلی از کارآزمایی بالینی ثبت شد
داده های تکمیلی از کارآزمایی بالینی ثبت شد
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.
the block randomization method will be used, and 11 blocks of 10 people will be created. Sealed Envelope online software will be used to create random codes. The number of patients in groups A and B in each block is equal, but the random sequence will differ.
In this studythe block randomization method will be used, and 11 blocks of 10 people will be created. Sealed Envelope online software will be used to create random codes. The number of patients with simple sampling method, they were numbered firstin groups A and then were divided into different groups based on a table ofB in each block is equal, but the random numberssequence will differ.
در این مطالعه، بیماران با روش نمونه گیری ساده، ابتدا شماره گذاری شدند و سپس بر اساس جدول اعداد تصادفی به گروه های مختلف تقسیم شدند.
از روش تصادفی سازی بلوک استفاده می شود و 11 بلوک 10 نفره ایجاد می شود. برای ایجاد کدهای تصادفی از نرم افزار آنلاین Sealed Envelope استفاده خواهد شد. تعداد بیماران در گروه های A و B در هر بلوک برابر است، اما توالی تصادفی متفاوت خواهد بود.
در این مطالعه،از روش تصادفی سازی بلوک استفاده می شود و 11 بلوک 10 نفره ایجاد می شود. برای ایجاد کدهای تصادفی از نرم افزار آنلاین Sealed Envelope استفاده خواهد شد. تعداد بیماران با روش نمونه گیری ساده، ابتدا شماره گذاری شدند و سپس بر اساس جدول اعداد تصادفی بهدر گروه های مختلف تقسیم شدندA و B در هر بلوک برابر است، اما توالی تصادفی متفاوت خواهد بود.
All Participants, Investigators, Outcome assessors, Data analyst, and quality controller are blinded. Due to the difference in the form of administration, the double dummy technique was used for blinding, as patients in the enoxaparin group received the injectable form of enoxaparin and placebo tablets, and the patients in the rivaroxaban group received the injectable form of placebo and rivaroxaban tablets.Placebo forms (both tablets and injectable forms) have the same shape, color and packaging as the original drug form.
All Participants, Investigators, Outcome assessors, Data analyst, and quality controller are blinded. Due to the difference in the form of administration, the double dummy technique was used for blinding, as patients in the enoxaparin group received the injectable form of enoxaparin and placebo tablets, and the patients in the rivaroxaban group received the injectable form of placebo and rivaroxaban tablets.Placebo forms (both tablets and injectable forms) have the same shape, color and packaging as the original drug form.
بیماران وارد شده در مطالعه، محققین، پزشکی که پاسخ به مداخلات را بررسی میکند، تحلیل کننده آماری داده ها و کنترل کننده کیفیت مطالعه همه کورسازی شده اند، جهت کورسازی با توجه به تفاوت شکل تجویز از تکنیک double dummy استفاده شد به این صورت که بیماران در گروه انوکساپارین ، فرم تزریقی انوکساپارین و قرص پلاسبو و بیماران گروه ریواروکسابان، فرم تزریقی پلاسبو و قرص ریواروکسابان را دریافت کردند. اشکال پلاسبو (چه قرص چه فرم تزریقی)دارای شکل و رنگ و بسته بندی مشابه با فرم اصلی دارو هستند.
بیماران وارد شده در مطالعه، محققین، پزشکی که پاسخ به مداخلات را بررسی میکند، تحلیل کننده آماری داده ها و کنترل کننده کیفیت مطالعه همه کورسازی شده اند، جهت کورسازی با توجه به تفاوت شکل تجویز از تکنیک double dummy استفاده شد به این صورت که بیماران در گروه انوکساپارین ، فرم تزریقی انوکساپارین و قرص پلاسبو و بیماران گروه ریواروکسابان، فرم تزریقی پلاسبو و قرص ریواروکسابان را دریافت کردند. اشکال پلاسبو (چه قرص چه فرم تزریقی)دارای شکل و رنگ و بسته بندی مشابه با فرم اصلی دارو هستند.
Recruitment centers
#1
Name of recruitment center - English: Imam hosein hospital
Name of recruitment center - Persian: بیمارستان امام حسین (ع)
Full name of responsible person - English: Hamidreza khayat kashani
Full name of responsible person - Persian: حمیدرضا خیاط کاشانی
Street address - English: Imam hosein hospital,Madani Ave,Nezamabad
Street address - Persian: نظام آباد،خیابان مدنی،بیمارستان امام حسین (ع)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1617763141
Phone: +98 21 7343 0000
Fax:
Email: hamidkhayat@yahoo.com
Web page address:
Name of recruitment center - English: Imam Hossein Hospital
Name of recruitment center - Persian: بیمارستان امام حسین (ع)
Full name of responsible person - English: Hamidreza Khayat Kashani
Full name of responsible person - Persian: حمیدرضا خیاط کاشانی
Street address - English: Imam hosein hospital,Madani Ave,Nezamabad
Street address - Persian: نظام آباد،خیابان مدنی،بیمارستان امام حسین (ع)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1617763141
Phone: +98 21 7343 0000
Fax:
Email: hamidkhayat@yahoo.com
Web page address:
Name of recruitment center - English: Imam hosein hospitalHossein Hospital Name of recruitment center - Persian: بیمارستان امام حسین (ع) Full name of responsible person - English: Hamidreza khayat kashaniKhayat Kashani Full name of responsible person - Persian: حمیدرضا خیاط کاشانی Street address - English: Imam hosein hospital,Madani Ave,Nezamabad Street address - Persian: نظام آباد،خیابان مدنی،بیمارستان امام حسین (ع) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1617763141 Phone: +98 21 7343 0000 Fax: Email: hamidkhayat@yahoo.com Web page address:
Protocol summary
Study aim
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
Supplementary data from the clinical trial was recorded
Acronym
IRCT registration information
IRCT registration number:IRCT20200808048333N1
Registration date:2021-10-29, 1400/08/07
Registration timing:registered_while_recruiting
Last update:2023-07-30, 1402/05/08
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
2020-08-22, 1399/06/01
Actual recruitment end date
2022-12-13, 1401/09/22
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
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
200
Actual sample size reached:
220
Randomization (investigator's opinion)
Randomized
Randomization description
the block randomization method will be used, and 11 blocks of 10 people will be created. Sealed Envelope online software will be used to create random codes. The number of patients in groups A and B in each block is equal, but the random sequence will differ.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All Participants, Investigators, Outcome assessors, Data analyst, and quality controller are blinded. Due to the difference in the form of administration, the double dummy technique was used for blinding, as patients in the enoxaparin group received the injectable form of enoxaparin and placebo tablets, and the patients in the rivaroxaban group received the injectable form of placebo and rivaroxaban tablets.Placebo forms (both tablets and injectable forms) have the same shape, color and packaging as the original drug form.
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
Shahid Beheshti University of Medical Sciences, Kudakyar street, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
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.