Aspirin efficacy for prevention of deep vein thrombosis in tibial shaft fractures
Design
A double-blinded study, computer-based randomized, two-arm parallel-group, phase two clinical trial that involves 460 patients. Patients use medication for 35 days after discharge and follow for 6 months.
Settings and conduct
Patients referred to Sina hospital with Tibial fracture; patients are divided into two groups. The first group undergoes Aspirin 325 mg BD, the second group undergoes Enoxaparin 30 mg. In the time of hospitalization, all patients see serial examinations to evaluate DVT. If clinical manifestations of DVT are observed, Doppler ultrasonography will preform. Patients will follow for six months, in the first week, the first month, the third month, and the sixth month after discharge, we will arrange meetings. Patients will be advised to refer to Sina hospital if clinical manifestations of DVT occur.
Patients will only enter the study with their consent and wouldn't notice the exact type of their anti-coagulant. This study is double-blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1.male and female patients between 14 to 85 years old; 2. Tibial fracture with or without surgery indication.
exclusion criteria:
1.hip or femur fracture; 2.major fracture except for tibia; 3.DVT or PTE history; 4.low platelet levels (lower than 100,000); 5.gustilo type 3B and higher open fractures; 6.patients that have a contraindication to using Aspirin or Heparin; 7.patients that avoid participating in the study; 8.patients with chronic kidney disease that have lower GFR than 30.
Intervention groups
1. Aspirin prescribed
2. Enoxaparin prescribed
Main outcome variables
Incidence for deep vein thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200202046344N1
Registration date:2020-09-29, 1399/07/08
Registration timing:registered_while_recruiting
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Ali Sheikhy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 1399
Email address
sheikhyali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Aspirin with Enoxaparin Sodium for prevention of deep vein thrombosis in Tibial fractures
Public title
Aspirin in DVT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and Females between 14 and 85 years old
Tibial fractures with or without surgery indication
Exclusion criteria:
Hip or femur fracture
Major fracture except tibia
DVT or PTE history
Low platelet levels (lower than 100,000)
Gustilo type 3B and higher open fractures
Patients that have contraindication to use Aspirin or Heparin
Patients that avoid to participate in the study
Patients with chronic kidney disease that have lower GFR than 30
Age
From 14 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
446
Randomization (investigator's opinion)
Randomized
Randomization description
All patients were divided into two groups with 1:1 proportion. For the first group, Aspirin will be prescribed, and for the second group, Enoxaparin will be prescribed. Randomization is completely computer-based.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, only the researcher will know about the prescribed medication. Patients and their physicians won't know about anticoagulants that prescribed. hence, patients will get inform that prescribed drugs have anticoagulation effects.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee ,School of Medicine, Tehran University of Medical Sciences
Street address
School of Medicine, Tehran University of Medical Sciences, Poor Sina street, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1967853916
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.255
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
Primary outcomes
1
Description
Incidence of deep vein thrombosis in lower extremity
Timepoint
At the end of first week, fourth week, 12th week, and 24th week after discharge
Method of measurement
Physical examinations an doppler ultra sonography
Secondary outcomes
1
Description
Peptic ulcer disease
Timepoint
At the end of first week, fourth week, 12th week, and 24th week after discharge
Method of measurement
Short questionnaire with 10 questions
Intervention groups
1
Description
Intervention group: patients with a tibial fracture will consume 80 mg Aspirin tablets produced by "Pars Daroo" every 12 hours for 35 days to prevent deep vein thrombosis.
Category
Treatment - Drugs
2
Description
Control group: patients with a tibial fracture will use Enoxaparin 30mg produced by "Osveh" every day for 35 days to prevent deep vein thrombosis.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Ali Sheikhy
Street address
Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
۱۱۳۶۷۴۶۹۱۱
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
sheikhyali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
6th floor, Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8163 3685
Email
msahrai@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Sheikhy
Position
Medical student
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
Imam khomeini
City
Tehran
Province
Tehran
Postal code
1967853916
Phone
+98 21 6634 8500
Email
a-sheikhy@student.tums.ac.r
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Shafiei
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
dr_hshafiei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Sheikhy
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 48, Shahid Ansari alley, Nelson Mandela blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1967853916
Phone
+98 21 2620 1399
Fax
Email
sheikhyali@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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The Trial result will completely present after completion of trial without the participant's personal information.
When the data will become available and for how long
after publication
To whom data/document is available
for the ones who ask for information
Under which criteria data/document could be used
citation to the published article
From where data/document is obtainable
Ali Sheikhy
email: a-sheikhy@student.tums.ac.ir
What processes are involved for a request to access data/document
contact Ali Sheikhy via email. if the condition accepted, data will send.