Comparison of the effect of heparin and enoxaparin in the occurrence of venous thromboembolism after abdominal surgery
Design
Clinical trial with parallel groups, unblinded and non-randomized phase 2 on 116 patients.
Settings and conduct
In the hospitals of Islamic Azad University of Tehran, after abdominal surgery, one group was injected with 60,000 units of intramuscular enoxaparin and the other group with 5,000 units of subcutaneous coarse heparin
Participants/Inclusion and exclusion criteria
All patients who have undergone abdominal surgery
Intervention groups
The study is designed to investigate the effectiveness
Main outcome variables
Investigating venous embolism following enoxaparin and heparin injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240923063130N1
Registration date:2024-11-14, 1403/08/24
Registration timing:registered_while_recruiting
Last update:2024-11-14, 1403/08/24
Update count:0
Registration date
2024-11-14, 1403/08/24
Registrant information
Name
Alma Zahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 1865
Email address
almazahedii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-26, 1403/08/05
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of heparin and enoxaparin in the occurrence of venous thromboembolism after abdominal surgery in operated patients
Public title
Comparison of the effects of heparin and enoxaparin in the occurrence of venous thromboembolism after abdominal surgery in operated patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent abdominal surgery in the hospitals of Islamic Azad University of Tehran during 2024
receiving heparin and enoxaparin thromboprophylaxis
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-05-20, 1403/02/31
Ethics committee reference number
IR.IAU.TMU.REC.1F0.091
Health conditions studied
1
Description of health condition studied
Venous thromboembolism
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism
Primary outcomes
1
Description
The occurrence of thromboembolism, age, gender, number of hospitalization days, drug complications
Timepoint
The sampling method was simple random sampling, and participants were assigned to case and control groups using a random number table or a lottery. The first group was the case or test group (receiving enoxaparin), and the second group was the control group (receiving heparin).
Method of measurement
According to a study, the sample size is calculated based on the reported incidence of venous thromboembolism, with 14% for the enoxaparin group and 18% for the placebo group, and it will be determined for the group receiving heparin.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: at the end of the operation of group one, N=58 heparin is injected subcutaneously in the amount of 5000 units and is repeated within 24 to 48 hours.
Category
Prevention
2
Description
Intervention group: at the end of the operation, group two, N=58, is injected with enoxaparin in the amount of 60,000 units of muscle and is repeated within 24 to 48 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Heydar Darvishi
Street address
Naziabad, amiralmomenin hospital
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
amhos@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad Gholamzad
Street address
Attari moghasam st, islamic azad university of medical sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 2260 0037
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Heydar Darvish
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Naziabad, amiralmomenin hospital
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
Hdarvishi@iauimuic.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Heydar Darvish
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Naziabad,Amiralmomenin hospital
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
Hdarvishi@iauimuic.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alma Zahedi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Qeytarie, 3rd west mehr, No 13
City
Tehran
Province
Tehran
Postal code
1933666546
Phone
+98 21 2239 1865
Email
almazahedii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available