Study the results of using of heparin aspirin protocol to prevent deep vein thrombosis and pulmonary embolism in total knee and hip arthroplasty patients
Aim was evaluation Study the results of using of heparin aspirin protocol to prevent deep vein thrombosis and pulmonary embolism in total knee and hip arthroplasty patients in Shafa Yahyaiean Hospital from 1397 to 1398
Design
This evaluation is a phase 3 clinical trial, with patients undergoing orthroscopy and meeting the stated inclusion criteria being considered as a study group. 100 patients based on inclusion criteria are selected. Patients undergo heparin-aspirin protocol after surgery and the results will evaluated.
Settings and conduct
The study will be a clinical trial at Shafa Yahyaian Hospital, also it is a non-randomized, non-randomized study.
Participants/Inclusion and exclusion criteria
Patients with age over 18 years and consent to participate in the study were enrolled to study, also patients with wound infection, failure to follow up and refer of patients, high risk of thromboembolism and high risk of cardiovascular disease were excluded from the study.
Intervention groups
Patients in study in the first 5 days after surgery are treated with heparin 5000 units twice daily and then aspirin 80 tablets take every 12 hours or aspirin 325 tablets take every day and after discharge in accordance with routine visits after 2, 6, 12 and 24 weeks follow-up is done.
Main outcome variables
Effect of Heparin-Aspirin protocol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170109031845N2
Registration date:2019-11-23, 1398/09/02
Registration timing:registered_while_recruiting
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Abolfazl Bagerifard
Name of organization / entity
Shafa orthopedic hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2041
Email address
bagheri.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the results of using of heparin aspirin protocol to prevent deep vein thrombosis and pulmonary embolism in total knee and hip arthroplasty patients
Public title
Effect of Heparin-Aspirin to prevent thrombosis of knee and hip arthroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Consent to participate in the study
Exclusion criteria:
Wound infection
Failure to follow up and refer of patients
High risk of thromboembolism
High risk of cardiovascular disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical
Street address
Next to Milad tower, Hammat highway.
City
Tehran
Province
Tehran
Postal code
1799737737
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.IUMS.FMD.REC.1398.180
Health conditions studied
1
Description of health condition studied
Deep vein 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
Effect of Heparin-Aspirin protocol
Timepoint
One month, two months and one year after surgery
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first 5 days after surgery with 5000 units of heparin twice daily and then aspirin tablets every 2 hours or sprays tablets daily and after routine discharge after 2, 6, 12 and 24 Patients are followed weekly.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Abolfazl Bagheri Fard
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2020
Email
Bagherifard@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
ivco@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Bagherifard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2001
Email
bagherifd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Bagherifard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2001
Email
bagherifd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Bagherifard
Position
دانشیار
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue.
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2001
Email
bagherifd@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