Comparison of the effects of oral and injectable antiquaguane in the prevention of thromboembolic events in patients with gynecological cancers who underwent surgery.
Determining and comparing the effects of oral and injectable anticoagulants in the prevention of thromboembolic events in patients with gynecological cancers who underwent surgery.
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 2 on 100 patients. A table of random numbers was used for randomization.
Settings and conduct
This study is conducted on women who had a history of surgery for gynecological cancers and are candidates for receiving oral or injectable anti coagulants. This study will be conducted in 2023 in Al-Zahra Hospital and Beheshti Hospital in Isfahan. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
This study is conducted on women who have a history of surgery for gynecological cancers and are candidates for receiving oral or injectable anticoagulants. People with a history of thromboembolic events will not be included in the study
Intervention groups
The intervention performed in this study is the administration of oral anticoagulant drug (Apixaban) in one group and the administration of injectable anticoagulant (Enoxaparin) in the other group.
Main outcome variables
Thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231026059867N1
Registration date:2023-11-08, 1402/08/17
Registration timing:prospective
Last update:2023-11-08, 1402/08/17
Update count:0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Seyede zahra Anaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3833 0206
Email address
mjp_368@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of oral and injectable antiquaguane in the prevention of thromboembolic events in patients with gynecological cancers who underwent surgery.
Public title
Oral and injectable antiquaguane in the prevention of thromboembolic events
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have undergone surgery for gynecological cancers
Candidate to receive oral or injectable anticoagulants
Exclusion criteria:
Lack of consent to continue participating in the study
History of thromboembolic events
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and done with the help of a table of random numbers. According to the number of participants in the study, a sequence of random numbers is created with the help of a random number table, and each number is placed in an aluminum envelope, and the back of the envelopes is numbered according to the sequence process. According to the order of entry into the study, an envelope is opened and the sequence number inside is determined. If the number is even, the person will be placed in the second group, and if the number is odd, the person will be placed in the first 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 Isfahan University of Medical Sciences
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-23, 1402/03/02
Ethics committee reference number
IR.MUI.MED.REC.1402.091
Health conditions studied
1
Description of health condition studied
Thrombosis
ICD-10 code
I82.4
ICD-10 code description
Acute embolism and thrombosis of deep veins of lower extremity
2
Description of health condition studied
Pulmonary embolism
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism
Primary outcomes
1
Description
Venous thrombosis
Timepoint
2 and 6 and 12 weeks after starting treatment
Method of measurement
Physical examination and history taking
2
Description
Pulmonary embolism
Timepoint
2 and 6 and 12 weeks after starting treatment
Method of measurement
Physical examination and history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving the oral anticoagulant apixaban tablets made in Elixir Pharmaceutical Company, 2.5 mg twice a day for 3 months.
Category
Treatment - Drugs
2
Description
Intervention group: Received the subcutaneous anticoagulant enoxaparin ampoule manufactured in Octorco pharmaceutical company, 40 mg once a day for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al zahra hospital
Full name of responsible person
Zahra Anaie
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mjp_368@yahoo.com
2
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Zahra Anaie
Street address
Beheshti street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mjp_368@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Anaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mjp_368@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Anaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mjp_368@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Anaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mjp_368@yahoo.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