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Comparison of the effect of oral anticoagulants (Rivaroxaban and Apixaban) and injectable drugs (Heparin and Enoxaparin) to prevent bleeding in patients undergoing oncological gynecological surgeries

Protocol summary

Study aim
Comparison of the effects of oral (rivaroxaban and apixaban) and injectable (heparin and enoxaparin) anticoagulant drugs in patients undergoing gynecological oncological surgeries
Design
This study is a open label clinical trial, with two parallel groups, randomized, phase 2 on 80 patients, which is conducted in two groups of 40 people receiving oral and injectable anticoagulants. The method of randomization is based on the table of random numbers.
Settings and conduct
This study is a open label clinical trial, with two parallel groups, randomized, phase 2 on 80 patients, which is conducted in two groups of 40 patients receiving oral and injectable anticoagulants on patients referred to Firouzgar Hospital in Tehran. The method of randomization is based on the table of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18 to 70 years Obtain informed consent Having cancer complications Exclusion Criteria: Liver and kidney failure (glomerular filtration rate (GFR) less than 30) Deep vein thrombosis (DVT) and Post-transplant erythrocytosis (PTE) History of GI Pregnancy and breast feeding Using anticoagulants
Intervention groups
All patients are treated with injectable anticoagulants (heparin and enoxaparin) before surgery and during hospitalization. After discharge from the hospital, patients are randomly divided into two groups of 40 people (the group receiving oral anticoagulants, apixaban and rivaroxaban=40 people with a dose of 2.5 mg twice a day after surgery and the group receiving injectable anticoagulants=40 people with a dose of 5,000 units once a day after surgery) and within 28 days they use two defined medical treatment protocols.
Main outcome variables
Bleeding in the organs, disorder in the size, shortness of breath, pain in the organs, swelling in the organs, chest pain, time of drug administration and Doppler ultrasound results of the organs.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220211053991N1
Registration date: 2023-06-12, 1402/03/22
Registration timing: registered_while_recruiting

Last update: 2023-06-12, 1402/03/22
Update count: 0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
amineh arab khazael mahabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7711 8432
Email address
amym.940225@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-09, 1402/03/19
Expected recruitment end date
2023-09-10, 1402/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral anticoagulants (Rivaroxaban and Apixaban) and injectable drugs (Heparin and Enoxaparin) to prevent bleeding in patients undergoing oncological gynecological surgeries
Public title
Comparison of the effects of Rivaroxaban and Apixaban with Heparin and Enoxaparin in patients undergoing gynecological oncological surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years Obtaining informed consent Cancer disease
Exclusion criteria:
Liver failure Deep vein thrombosis (DVT) History of Gastrontestinal bleeding Pregnancy Taking other anticoagulants Breast feeding Post-transplant erythrocytosis (PTE) PTE disorders Kidney failure (glomerular filtration rate (GFR) less than 30)
Age
From 18 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Referral patients are randomly divided into two groups receiving oral and injectable anticoagulation drugs. Random number table is used for randomization. Odd numbers for the oral anticoagulation group and even numbers for the injectable drug group.
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 Iran University of Medical Sciences
Street address
Hemmat highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-07-08, 1400/04/17
Ethics committee reference number
IR.IUMS.FMD.REC.1400.190

Health conditions studied

1

Description of health condition studied
Women's cancers including: endometrium, ovary, cervix, vulva
ICD-10 code
C55
ICD-10 code description
Malignant neoplasm of uterus, part unspecified

Primary outcomes

1

Description
Shortness of breath
Timepoint
Before and after surgery
Method of measurement
Examination

Secondary outcomes

1

Description
Bleeding
Timepoint
Before and after surgery
Method of measurement
Examination

2

Description
Pain
Timepoint
Before and after surgery
Method of measurement
Examination

3

Description
Size of organ
Timepoint
Before and after surgery
Method of measurement
Examination

4

Description
Time to take the medicine
Timepoint
Before and after surgery
Method of measurement
Questionnaire

5

Description
Doppler ultrasound results
Timepoint
Before and after surgery
Method of measurement
ultrasound

6

Description
Swelling of the limbs
Timepoint
Before and after surgery
Method of measurement
Examination

Intervention groups

1

Description
The first intervention group: the group receiving oral anticoagulant tablets apixaban and rivaroxaban with a dose of 2/5 mg twice a day after surgery, for 28 days, manufactured by Aburihan Pharmaceutical Company of Iran.
Category
Treatment - Drugs

2

Description
Intervention group: The group receiving anticoagulation injection drugs (heparin and enoxaparin), with a dose of 5,000 units once a day after surgery, for 28 days, manufactured by Aburihan Pharmaceutical Company of Iran.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Amine Arab
Street address
Vali asr SQ, Beafariد Av
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 6646 7901
Email
h_firoozgar@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Kiwani
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Amine Arab
Position
STUDENT
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
amym.940225@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amine arab
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
00921886702503
Email
amym.940225@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amine Arab
Position
student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
amym.940225@gmail.com

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
Patient information is confidential according to the ethical work protocol
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only the results of the article are published, keeping the confidentiality of the patients' information.
When the data will become available and for how long
A month after the publication of the article
To whom data/document is available
University researchers
Under which criteria data/document could be used
Therapeutic use of the results of this study.
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document
Refer to supervisor keyvani.h@iums.ac.ir
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