1. Home
  2. Approved trials
  3. » فارسی

Comparison of the preventive effects of Apixaban and Enoxaparin on the postoperative vascular thromboembolism in patients undergoing surgery with gynecological and colorectal cancers

Protocol summary

Study aim
Comparison of the preventive effects of Apixaban and Enoxaparin on the postoperative vascular thromboembolism in patients undergoing surgery with gynecological and colorectal cancers
Design
Inclusion criteria: Patients diagnosed with gynecological and colorectal cancers undergo laparotomy surgery. Criteria for not entering: Patients with the use of non-steroidal anti-inflammatory drugs for more than one year, having other types of cancers, a history of thromboembolism, having severe kidney or liver diseases, having coagulation or bleeding disorders, using thrombogenic drugs, and pregnancy or breastfeeding.
Settings and conduct
In both groups, Heparin (5000 units, subcutaneous) is injected 30 minutes before skin incision. 18 to 24 hours after the termination of the operation, 0.5 mg/kg enoxaparin is injected subcutaneously and continues until discharge per day. After discharge for 28 days, in the intervention group, 2.5 mg of apixaban (Exir, Iran) will be administered orally twice a day and in the control group, 0.5 mg/kg enoxaparin will be administered subcutaneously.
Participants/Inclusion and exclusion criteria
Phase 3 clinical trial with a control group, parallel design, and randomized is performed on 160 patients.
Intervention groups
This randomized study will be performed on 160 patients diagnosed with gynecological and colorectal cancers who undergo laparotomy surgery in Baqiyatallah Hospital. This is a single-blind study, the study outcome assessor does not know the type of treatment.
Main outcome variables
The incidence of major bleeding or non-major bleeding with clinical significance till the first 90 days after the surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230419057967N1
Registration date: 2023-12-09, 1402/09/18
Registration timing: prospective

Last update: 2023-12-09, 1402/09/18
Update count: 0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Farima Takizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 477 0768
Email address
farimatakizad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the preventive effects of Apixaban and Enoxaparin on the postoperative vascular thromboembolism in patients undergoing surgery with gynecological and colorectal cancers
Public title
Comparison of the preventive effects of Apixaban and Enoxaparin on the postoperative vascular thromboembolism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with gynecological or colorectal cancers (rectum and colon) undergo laparotomy.
Exclusion criteria:
Use of non-steroidal anti-inflammatory drugs for more than one year Having other types of cancers History of thromboembolism Having severe kidney or liver diseases Having coagulation or bleeding disorders Using thrombogenic drugs Pregnancy or breastfeeding
Age
From 18 years old to 89 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 160
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
Ethics committee of Bagheiat-allah University of Medical Sciences
Street address
Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2023-09-30, 1402/07/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.064

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
The occurrence of major bleeding including hematoma and pelvic and abdominal bleeding
Timepoint
Three times, 30, 60 and 90 days after surgery
Method of measurement
Clinical symptoms and paraclinical findings

2

Description
Non-major bleeding incidence with clinical significance (requiring intervention)
Timepoint
Three times, 30, 60 and 90 days after surgery
Method of measurement
Clinical symptoms and paraclinical findings

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 5000 units of Heparin (Caspiantamin, Iran) are injected 30 minutes before skin incision, subcutaneously. 18 to 24 hours after the termination of the operation, 0.5 mg/kg enoxaparin (Iran Hormone, Iran) is injected subcutaneously and continues until discharge per day. After discharge for 28 days, 2.5 mg of apixaban (Exir, Iran) will be administered orally twice a day.
Category
Prevention

2

Description
Control group: 5000 units of Heparin (Caspiantamin, Iran) are injected 30 minutes before skin incision, subcutaneously. 18 to 24 hours after the termination of the operation, 0.5 mg/kg enoxaparin (Iran Hormone, Iran) is injected subcutaneously and continues until discharge per day. After discharge for 28 days, 0.5 mg/kg enoxaparin will be administered subcutaneously daily for 28 days.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bagheiat-allah Hospital
Full name of responsible person
Farima Takizad
Street address
Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
farimatakizad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Bagheiat-allah University of Medical Sciences, Dr. Saberi
Street address
Vice-Dean of Research, Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 7457
Email
msaberi@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Farima Takizad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Fax
Email
farimatakizad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Farima Takizad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Fax
Email
farimatakizad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Farima Takizad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bagheiat-allah Hospital, Mullasadra Street, Vanak Square.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Fax
Email
farimatakizad@yahoo.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.Takizad and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Takizad through email (farimatakizad@yahoo.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. Takizad.
Comments
Loading...