A clinical trial on the effectiveness of sensitivity and specificity of three-point compression ultrasonography with bedside and conventional methods in diagnosis of deep vein thrombosis
The comparison of sensitivity and specificity of three-point compression ultrasonography with bedside and conventional methods in diagnosis of deep vein thrombosis
Design
This clinical trial, 70 patients with deep vein thrombosis were assigned base on community-based setting
Settings and conduct
Totally 70 patients with suspected deep vein thrombosis at the Imam Khomeini Hospital, Sari, Iran, were chosen.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age higher than 18 years; patients with suspected deep vein thrombosis.
Exclusion criteria: Having pulmonary embolism disease; previous doppler ultrasound.
Intervention groups
The intervention group I were diagnosis of deep venous thrombosis base on three-point compression ultrasonography with bedside method by emergency residents. The intervention group II were diagnosis of deep venous thrombosis base on three-point compression ultrasonography with conventional method by emergency residents.
Main outcome variables
Evaluation and comparison of disease diagnose time and imaging results of intravenous vessels of the lower limbs include common femoral, saphenous and popliteal veins base on Bedside and Conventional methods.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190309042978N1
Registration date:2019-03-18, 1397/12/27
Registration timing:prospective
Last update:2019-03-18, 1397/12/27
Update count:0
Registration date
2019-03-18, 1397/12/27
Registrant information
Name
Hamed Jafarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
h.jafarpour1@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effectiveness of sensitivity and specificity of three-point compression ultrasonography with bedside and conventional methods in diagnosis of deep vein thrombosis
Public title
Sensitivity and specificity of three-point compression ultrasonography in diagnosis of deep vein thrombosis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age higher than 18 years
Patients with suspected deep vein thrombosis
Exclusion criteria:
Having pulmonary embolism disease
Previous doppler ultrasound
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Farah Abad Road
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR.MAZUMS.REC.1397.84
Health conditions studied
1
Description of health condition studied
Deep vein thrombosis
ICD-10 code
I80.2
ICD-10 code description
Phlebitis and thrombophlebitis of other deep vessels of lower extremities
Primary outcomes
1
Description
Diagnose time
Timepoint
At the time of patient referral
Method of measurement
Base on Bedside and Conventional methods
2
Description
Imaging results of intravenous vessels of the lower limbs include common femoral, saphenous and popliteal veins
Timepoint
At the time of patient referral
Method of measurement
Base on Bedside and Conventional methods
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group I were diagnosis of deep venous thrombosis base on three-point compression ultrasonography with bedside method by emergency residents.
Category
Diagnosis
2
Description
Intervention group: The intervention group II were diagnosis of deep venous thrombosis base on three-point compression ultrasonography with conventional method by emergency residents.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Fateme Jahanian
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Saeidi
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Farah Abad Road
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Email
Admission@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Jahanian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Jahanian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Jafarpour
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
h.jafarpour@mazums.ac.ir
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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Hamed Jafarpour provides the analysis code to the applicants via email: h.jafarpour@mazums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.