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Comparison of the efficacy and safety of rivaroxaban and heparin and enoxaparin as thromboprophylaxis agents for gynecology oncologic surgery

Protocol summary

Study aim
Comparison of the efficacy and safety of rivaroxaban, heparin, and enoxaparin as thromboprophylaxis agents for gynecologic oncology surgery .
Design
A prospective, randomized, phase 3, clinical trial conducted on 90 patients who undergoing of gynecologic oncology surgeries. The blocked randomization method (6 blocks) will be used for randomization.
Settings and conduct
The patients who will refer to Amir Al Momenin hospital, Semnan for gynecologic oncology surgery will be enrolled and the effect of rivaroxaban, heparin, and enoxaparin evaluated as thromboprophylaxis after surgery. The evaluation will be done on the 7th, 14th, and 30th days after surgery.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age, candidates for gynecological oncology surgery (staging, tumor mass reduction, radical hysterectomy, unilateral or bilateral salpingo-oophorectomy, resection of lymph nodes) will be enrolled in the study. Patients who receiving anticoagulants, cases with contraindications to anticoagulants, patients with stroke, acute ischemia, myocardial infarction, or dysrhythmias are excluded.
Intervention groups
In group 1, patients receive rivaroxaban 10 mg daily, for 30 days after surgery. In group 2, patients receive enoxaparin daily (40 mg for patients with weight under 90 kg, and 60 mg for weight over 90 kg) via subcutaneous injection, which continues for 30 days after surgery. The third group will receive unfractionated heparin, 5000 units via subcutaneous injection (for patients with weight under 90 kg every 12 hours and every eight hours for weight over 90 kg ) until discharge time and will continue for 30 days after surgery.
Main outcome variables
The primary outcome is symptomatic confirmed VTE, deep venous thrombosis, pulmonary embolism, and asymptomatic DVT- or VTE-related death within 30 days.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151020024625N19
Registration date: 2024-05-29, 1403/03/09
Registration timing: registered_while_recruiting

Last update: 2024-05-29, 1403/03/09
Update count: 0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of rivaroxaban and heparin and enoxaparin as thromboprophylaxis agents for gynecology oncologic surgery
Public title
Rivaroxaban, heparin and enoxaparin as thromboprophylaxis agents for gynecology oncologic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for gynecologic oncologic surgery
Exclusion criteria:
Receiving anticoagulants agents at present Contraindication for anticoagulants Uncontrolled cardiovascular and cerebrovascular diseases
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention groups is done by block randomization (six blocks) in Excel software. In this software, treatment and control groups are placed as every other two at first column. Six blocks are placed in the next column. Finally, the random numbers created by the random number generation software are placed. Then we will arrange the numbers based on the block and random numbers columns.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the datasheet, the names of the intervention groups will not be mentioned, so the data analyser will not know about the content of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.SEMUMS.REC.1402.223

Health conditions studied

1

Description of health condition studied
Venous thromboembolism
ICD-10 code
I82
ICD-10 code description
Other venous embolism and thrombosis

2

Description of health condition studied
Pulmonary embolism
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism

Primary outcomes

1

Description
Presence of venous thromboembolism
Timepoint
Seven, 14 and 30 days after surgery
Method of measurement
Doppler ultrasound

Secondary outcomes

1

Description
Venous thromboembolism related mortality
Timepoint
Up to 30 days after surgery
Method of measurement
Death of the patient

Intervention groups

1

Description
Intervention group: In group 1, patients receive rivaroxaban 10 mg once a day for 30 days after surgery and discharge from the hospital.
Category
Prevention

2

Description
Intervention group: In group 2, patients received enoxaparin 40 to 60 mg by subcutaneous injection once a day based on weight (weight under 90 kg 40 mg and weight over 90 kg 60 mg) and will continue for 30 days after surgery.
Category
Prevention

3

Description
Intervention group: The third group received unfractionated heparin, 5000 units (for weight below 90 kg every 12 hours and for weight above 90 kg every eight hours) until discharge and will continue for 30 days after the operation by subcutaneous injection.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al Momenin hospital
Full name of responsible person
Elham Saffarieh
Street address
Shahid Moustafa Khomeini Boulevard
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
eli_saffarieh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
majidmirmohammadkhani@yahoo.com
Web page address
https://rtvc.semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Elham Saffarieh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Moustafa Khomeini Blvd.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
eli_saffarieh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Saffarieh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Moustafa Khomeini Blvd.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
eli_saffarieh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researchman
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Amin Ave., Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3519899558
Phone
+98 23 3142 2250
Email
mehrdadzahmatkesh@semums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be provided anonymously in the Excel file.
When the data will become available and for how long
Access date is 6 months after publishing the final.
To whom data/document is available
Access to the data will be possible for academic researchers.
Under which criteria data/document could be used
The data can be used for further studies and meta-analyses.
From where data/document is obtainable
Contact with the scientific responsible of the study via email.
What processes are involved for a request to access data/document
After receiving of the request by e-mail, it will be sent at the latest the day after receiving the request.
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