Evaliuation of the two different enoxaparin regimen in prophylaxis for deep venous thrombosis
Design
Clinical trial with control group on 60 patients, block randomization was used.
Settings and conduct
Loghman Hakim Hospital, Tehran
Participants/Inclusion and exclusion criteria
In this study, patients who are between 18 and 65 years old and are candidate for receiving enoxaparin for prophylaxis of deep vein thrombosis included. Those patients who are in critically state or at hemorrhage risk will be excluded.
Intervention groups
Patients in group one receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 40 mg/day through subcutaneous route and patients in group two receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 1 mg/kg/day through subcutaneous route.
Main outcome variables
The activity level of anti-Xa, occurrence rate of venous thromboembolism, occurrence rate of adverse drug reactions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130917014693N11
Registration date:2020-05-18, 1399/02/29
Registration timing:retrospective
Last update:2020-05-18, 1399/02/29
Update count:0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Evaluation of the Two Different Enoxaparin Regimen in the Prophylaxis of Deep Venous Thrombosis
Public title
Evaluation of the Enoxaparin in the Prophylaxis of Deep Venous Thrombosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years old
Padua risk score ≥ 4 points
Signing the informed consent form
Exclusion criteria:
Patients in shock state
Acute kidney injury
Chronic kidney injury
History of hemorrhage in past one month
Invasive surgical procedures which needs to enoxaparin discontinuation
Pregnancy
Lactation
Thrombophilia
Antithrombin deficiency
Previous history of venous thrombosis
Body mass index more than 35 kg/m2
Platelet less than 50000 cells/uL
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method was used and 15 blocks which consist of 4 patient in each block, will be generated through online randomization website. In each block, two patients allocated to group one (Enoxaparin at dose of 40 mg/day) and two patients allocated to group two (Enoxaparin at dose of 1 mg/kg/day). Then, sampling will be done through individual sampling method.
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
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.069
Health conditions studied
1
Description of health condition studied
Deep vein thrombosi
ICD-10 code
I82
ICD-10 code description
Other venous embolism and thrombosis
Primary outcomes
1
Description
The activity level of anti factor Xa
Timepoint
Three hours after third doses
Method of measurement
Chromogenic assay
Secondary outcomes
1
Description
occurance rate of deep vein thrombosis
Timepoint
Daily
Method of measurement
Clinical examination and sonography is necessary cases
2
Description
Occurrence rate of adverse drug reactions
Timepoint
Daily
Method of measurement
Observation
Intervention groups
1
Description
Control group: Patients receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 40 mg/day through subcutaneous route.
Category
Prevention
2
Description
Intervention group: Patients receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 1 mg/kg/day through subcutaneous route.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Zahra Sahraei
Street address
Loghman Hakim Hospital, Kamali St, Makhsoos St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
zahra.sahraei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Loghman Hakim Hospital, Kamali St, Makhsoos St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
zahra.sahraei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Zahra Sahraei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Loghman Hakim Hospital, Kamali St, Makhsoos St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Fax
Email
zahra.sahraei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Saffaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
alisaffaei.ss@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All potential data can be shared after blinding
When the data will become available and for how long
Six mounts after results published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta analysis
From where data/document is obtainable
Dr. Zahra Sahraei, Loghman Hakim Hospital, Kamali St, Makhsoos St, Tehran
What processes are involved for a request to access data/document