Comparison of the effect of apixaban and enoxaparin on the prevention of postoperative vascular thromboembolism in women undergoing surgery for gynecological cancers
Comparison of the effect of apixaban and enoxaparin on the prevention of postoperative vascular thrombosis in women undergoing surgery for gynecological cancers
Design
Phase 3 clinical trial with a control group, parallel design, and randomized is performed on 200 patients.
Settings and conduct
This randomized study will be performed on 200 patients diagnosed with gynecological cancers who undergo laparotomy surgery in Imam Khomeini Hospital Complex. This is a single-blind study, the study outcome assessor does not know the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with gynecological cancers undergo laparotomy surgery. Criteria for not entering: Patients with the use of non-steroidal anti-inflammatory drugs, coagulation or bleeding disorders, severe kidney or liver diseases, valvular heart diseases, using thrombogenic drugs, selective serotonin reuptake inhibitors, or serotonin-norepinephrine reuptake inhibitors, history of venous thromboembolism.
Intervention groups
In the intervention group, enoxaparin (0.5 mg/kg) will be injected subcutaneously 12 hours before surgery, then 2.5 mg apixaban will be administered orally twice a day for 28 days. In the control group, enoxaparin (0.5 mg/kg) will be injected subcutaneously 12 hours before surgery, then enoxaparin (0.5 mg/kg) will be administered subcutaneously daily for 28 days.
Main outcome variables
The incidence of major bleeding or non-major bleeding with clinical significance till the first 30 days of after the surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141231020504N2
Registration date:2023-05-03, 1402/02/13
Registration timing:prospective
Last update:2023-05-03, 1402/02/13
Update count:0
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Arezoo Esmailzadeh
Name of organization / entity
Tehran University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
dr.a.esmailzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of apixaban and enoxaparin on the prevention of postoperative vascular thromboembolism in women undergoing surgery for gynecological cancers
Public title
Comparison of the effect of apixaban and enoxaparin on the prevention of postoperative vascular thromboembolism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with gynecological cancers (ovarian, uterine, cervical, or vulvar) undergo laparotomy surgery.
Exclusion criteria:
Long-term use of non-steroidal anti-inflammatory drugs
Patients with coagulation or bleeding disorders, severe kidney or liver diseases, valvular heart diseases
Using thrombogenic drugs, selective serotonin reuptake inhibitors, or serotonin-norepinephrine reuptake inhibitors
History of venous thromboembolism
Age
From 18 years old to 89 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method: Patients will be placed in two groups receiving apixaban group and enoxaparin group in a ratio of 1:1 using random blocks of four. In addition, interventions A (apixaban) or B (enoxaparin ) are determined by a lot.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is performed single-blind, the study outcome assessor does not know the patient groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran Uviversity of Medical Science
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.176
Health conditions studied
1
Description of health condition studied
Venous embolism and thrombosis
ICD-10 code
I82
ICD-10 code description
Other venous embolism and thrombosis
Primary outcomes
1
Description
Major bleeding incidence
Timepoint
Once, 30 days after the surgery
Method of measurement
Questioning
2
Description
Non-major bleeding incidence with clinical significance (requiring intervention)
Timepoint
Once, 30 days after the surgery
Method of measurement
Questioning
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 12 hours before surgery, 0.5 mg/kg enoxaparin (Iranhormone, Iran) will be injected subcutaneously, then 2.5 mg apixaban (Exir, Iran) will be administered orally twice a day for 28 days.
Category
Prevention
2
Description
Control group: In the control group, 12 hours before surgery, 0.5 mg/kg enoxaparin (Iranhormone, Iran) will be injected subcutaneously. Then, 0.5 mg/kg enoxaparin will be administered subcutaneously daily for 28 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Arezoo Esmailzadeh
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2755
Email
dr.a.esmailzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Fotuohi
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3689
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Esmailzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
dr.a.esmailzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Esmailzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
dr.a.esmailzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Esmailzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
dr.a.esmailzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified
participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr.
Esmailzadeh and any analysis must be done with her
opinion.
From where data/document is obtainable
Dr. Esmailzadeh through email (dr.a.esmailzadeh@gmail.com)
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied
by a proposal with an ethics code under the supervision
of Dr. Esmailzadeh.