Protocol summary

Study aim
The effects of aspirin and enoxapirin with the control group in prevention of DVT, PTE , hemarthrose , tromboprolphylaxy after arthroscopy ACL construction surgery
Design
Single center, 3 parallel groups, randomized trial with blinded, on 138patients. random allocation software was used to randomization.
Settings and conduct
This study is being performed at Taleghani Hospital Patients follow up continues for 4 weeks after surgery. To check out pTE used to weekly examination for 4 weeks and current description will be taken and in suspicious cases used CT angiography with contrast. To check out the DVT before surgery, during the release and 4 weeks after the release, bilateral doppler sonography of the lower body will be done. But the examination of DVT symptoms done weekly, and at any time of follow up if incidence warning symptoms bilateral doppler sonography of the lower body will be done for patient. The strong test is used to check out the effusion and hemarthrosis, wit the score as per the results of the examination and included in as open range of 0 to 3 From the beginning of the study, groups were identified by name and code, and the patient, the physician, data collector and Data analysis specialist were blind about grouping.
Participants/Inclusion and exclusion criteria
\atients with ACL rupture diagnosed in MRI Entered the study. Age under 18 and over 45 year old, BMI over 30, other ligament damage, the same side damage, smokers, have a DVT history, cancer or active infection, have anemia, allergy to aspirin or enoxapirin, background of coagulation disorders will be excluded from our study.
Intervention groups
Intervention 1: aspirin daily for 14 days Intervention 2: prescribed SQ injection of enoxapirin for 14 days Control: receive none of anticoagulant drug as a control group.
Main outcome variables
DVT؛ PTE؛ effusion؛ hemarthrosis.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170807035554N2
Registration date: 2020-06-21, 1399/04/01
Registration timing: retrospective

Last update: 2020-06-21, 1399/04/01
Update count: 0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
arash sajadi
Name of organization / entity
shaheed beheshti university of medicalscience
Country
Iran (Islamic Republic of)
Phone
+98 912 337 7215
Email address
arashsajadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of thromboprophylactic drugs on post-operative complications of arthroscopic ACL reconstruction surgery
Public title
The effect of thromboprophylactic drugs on post-operative complications of arthroscopic ACL surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 45 years old Patient with ACL rupture diagnosed in MRI Entered the study
Exclusion criteria:
Patients with other ligament injuries in addition to ACL Patients with concomitant damage in the same side long osseous Patients who need other procedures that interfer With rehabilitation after surgery Having a history of DVT Patient who were under thromboprophylaxis before surgery
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 2 intervention groups an 1 control group. The randomization method will done using software, 46 random numbers for each intervention group. The researcher can not play a role in predicting treatment of the disease, and choosing the type of treatment. random sequence will generate by software. َAll 138 Admitted individuals fall into one of three groups according to a predetermined code
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, blinding is performed at three levels: patient, physician, and data analyzer; So that the drugs are packaged and coded in dark paper packages. As a result, the patient, physician, and person in charge of the analysis are not informed of the type of medication prescribed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti university of medical science
Street address
Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2019-11-09, 1398/08/18
Ethics committee reference number
IR.SBMU.MSP.REC.1398.791

Health conditions studied

1

Description of health condition studied
post-operative complications of arthroscopic ACL reconstruction
ICD-10 code
S83.7
ICD-10 code description
Injury to multiple structures of knee

Primary outcomes

1

Description
Deep vein thrombosis (DVT)
Timepoint
14 and 28 days after surgery
Method of measurement
ٍWith examination and Doppler ultrasound

2

Description
Venous thromboembolism (VTE)
Timepoint
14 and 28 days after surgery
Method of measurement
with contrast methods and computed tomography (ct angiography)

3

Description
hemarthrosis and opioids
Timepoint
14 and 28 days after surgery
Method of measurement
Examination methods and score according to the stroke table

4

Description
Intraspinal bleeding
Timepoint
14 and 28 days after surgery
Method of measurement
Examination

5

Description
Operative bleeding
Timepoint
14 and 28 days after surgery
Method of measurement
Examination

6

Description
Retroperitoneal bleeding
Timepoint
14 and 28 days after surgery
Method of measurement
Examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: (1) start up 80 mg aspirin daily for 14 days
Category
Treatment - Drugs

2

Description
Intervention group: (2) prescribed SQ injection of enoxapirin 40 for 14 days
Category
Treatment - Drugs

3

Description
Control: receive none of anticoagulant drug as a control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Mohammadreza Minator Sajjadi
Street address
Next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2020
Email
arashsajadi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Taleghani Hospital Research Development committee
Full name of responsible person
Mahshid Mehdipour
Street address
Next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
Email
arashsajadi@sbmu.ac.ir
Grant name
Not used
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Taleghani Hospital Research Development committee
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2560
Email
arashsajadi@sbmu.ac.ir
Grant name
No
Grant code / Reference number
خیر
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
Mohammadreza Minator Sajjadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2240 2020
Email
arashsajadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Minator Sajjadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
0098 22402020
Email
arashsajadi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Minator Sajjadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2240 2020
Email
okhovatpour@sbmu.ac.ir

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
All data can be shared potentially after patients became unrecognizable
When the data will become available and for how long
After completing the results and analyzing the data, access to them is allowed
To whom data/document is available
This is only available for people working in academic institutions
Under which criteria data/document could be used
This is only available for people working in academic institutions
From where data/document is obtainable
After obtaining written permission, the use of the data is permitted with reference to the source. Dr Mohammadreza Sajjadi, 09123377215
What processes are involved for a request to access data/document
After completing the results and analyzing the data, the use of the data is allowed after the written request.
Comments
Loading...