Evaluation of safety and efficacy of PDxane® vs Clexane® in prophylaxis of venous thromboembolism in Major Gynecology Surgeries
Design
Single Blind randomized clinical trial, interventional groups with 100 patients, randomization with Randomization block method.
Settings and conduct
This study will be performed in Gynecology ward of Dr.Shariati Hospital, Tehran, Iran since March 2016. According to the Latest National Guideline of Gynecology surgeries, the subcutaneous dose of 40 mg enoxaparin every 24 hours for patient with less than 90 kilograms and 60 mg enoxaparin every 24 hours will be prescribed for indication of thromboprophylaxis.The initial dose of anticoagulant for each patient will be administrated at the hospital and rests of medications will be injected by the patients after discharge.All the patients individually would be educated about the impact of anticoagulants in their treatment process, self-injection of subcutaneous anticoagulant and how to manage the probable side effects of medications.
Participants/Inclusion and exclusion criteria
In:
Adult (aged 18+)
Major Gynecology Surgeries
Ex :
Having clinical symptoms of thrombosis
having active hemorrhage or a high risk of bleeding
History of thromboembolic diseases
Malignancy
Severe renal impairment
Significant liver disease
Treatment with warfarin
Pregnancy
Intervention groups
intervention : PDxane® 40 mg SC if <90 kg and 60 mg if > 90 kg for 10 days, control: Clexane® 40 mg SC if<90 kg and 60 mg if> 90 kg for 10 days
Main outcome variables
1- Evaluation of effectiveness ,Prevention of thrombosis and/or Pulmonary Thromboembolism, Changes in the active component of thromboplastin (APTT) and Thrombin clotting time (TCT)2- Evaluation of unwanted side effects ,Postoperative bleeding, Hematoma in the surgical site, Infections in the surgical site, Itching and allergy to the drug, Hematoma in injection site)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090914002459N2
Registration date:2018-06-10, 1397/03/20
Registration timing:retrospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
84902364
Email address
mrjavadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of PDxane® in comparison to Clexane® in prophylaxis of venous thromboembolism in Major Gynecology Surgeries
Public title
Evaluation of safety and efficacy of PDxane® in comparison to Clexane® in prophylaxis of venous thromboembolism in Major Gynecology Surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Major Gynecology Surgeries
Adult (aged 18 and more)
Exclusion criteria:
Having clinical symptoms of Venus thrombosis
Having active bleeding or a high risk of bleeding
History of thromboembolic diseases
Malignancy
Pregnancy
Severe renal impairment
Significant liver disease
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The primary investigator, researcher who perform outcome assessment and the analyst are not aware of allocations. A randomized list would be provided to pharmacy personnel and he will allocate patients based on the list and deliver the appropriate medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Jalal ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2016-02-14, 1394/11/25
Ethics committee reference number
IR.TUMS.REC.1394.1956
Health conditions studied
1
Description of health condition studied
Venous Thromboembolism fallowing major gynecology surgery
ICD-10 code
I74.9
ICD-10 code description
Embolism and thrombosis of unspecified artery
Primary outcomes
1
Description
prevention of Venous Thromboembolism
Timepoint
10 days after surgery
Method of measurement
History taking and clinical assessments
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : Receiving an enoxaparin drug with the PDxane® brand to test the effects of thrombophilaxy and side effects.
Category
Prevention
2
Description
Intervention group2: Receiving an enoxaparin drug with the Clexane® brand to test the effects of thrombophilaxy and side effects.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mohammadreza Javadi
Street address
Jalal ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0218 4901
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pooyesh Darou Pharmaceuticals Co.
Full name of responsible person
Sina Ebrahimi
Street address
No466, Vali e asr Ave.Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8894 7910
Email
info@pooyeshdarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pooyesh Darou Pharmaceuticals Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Javadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr.Shariatie Hospital, Jala ale ahmad Highway,
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0218 4901
Email
mrjavadi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Javadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr.Shariati Hospital, JalaleAleAhmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0218 4901
Email
mrjavadi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Javadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr.Shariati Hospital, Jalal-e-Al-e-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0218 4901
Email
mrjavadi@tums.ac.ir
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
Considering potential conflicts in this study in which the efficacy and safety of two brands of a medication are compered, dissemination of original data set would not be feasible.
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