Protocol summary

Summary
The purpose of this study is to compare disposition time in patient suspicious to deep vein thrombosis by venous compression ultrasound exam done by emergency medicine and radiology residents. Study is not blinded randomized clinical trial. 50 patients with suspected lower extremity DVT attending to Shariati Hospital emergency department in1393-1394, randomly divided to two groups and evaluated by venous compression ultrasound study by emergency medicine resident or radiology resident. The inclusion criteria was: patient informed consent; suspicion to DVT and exclusion criteria was history of Documented DVT by ultrasound exam before coming to emergency department and history of chronic DVT .Mean disposition time (specific treatment initiation or discharge) in these two groups was compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101229220N2
Registration date: 2016-12-04, 1395/09/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-04, 1395/09/14
Registrant information
Name
Golnaz Bashizadeh Fakhar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 1064
Email address
gbashizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of medical sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of performing venous compression ultrasonography by emergency department group in comparison with radiology group in managing patients attending to the emergency department of Shariati Hospital in 1393-1394 with suspected deep vein thrombosis
Public title
Effect of ultrasonographic exam by emergency medicine doctors on management time in comparison by radiologists in patients with Dvt in lower extrimitie
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:Informed consent;suspicion to DVT Exclusion criteria:History of DVT confirmed by ultrasonography before coming to emergency room;history of chronic DVT
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
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
Tehran University of medical sciences medical ethics committee
Street address
Ghods street,Keshavars ave,Tehran,Iran
City
Tehran
Postal code
Approval date
2014-05-24, 1393/03/03
Ethics committee reference number
9211307030

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 Deep vein thrombosis NOS

Primary outcomes

1

Description
Management time in patients with suspected deep vein thrombosis of the lower extremities
Timepoint
Right after intervention
Method of measurement
Minute

Secondary outcomes

empty

Intervention groups

1

Description
Deep vein thrombosis ultrasonography by emergency medicine resident
Category
Diagnosis

2

Description
Deep vain thrombosis ultrasonography by radiology resident
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr.Arash Fadavi
Street address
Jalal Al Ahmad street,North Kargar street,Tehran ,Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
dr.Shahin Akhoond zadeh
Street address
Room number206,Bulding 1,1th floor,University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of medical sciences
Full name of responsible person
Dr.Arash Fadavi
Position
Emergency medicine resident
Other areas of specialty/work
Street address
No30,4th Sepehr street,Sepehr street,Marzdaran ave
City
Tehran
Postal code
Phone
+98 21 4429 7136
Fax
Email
arash_fadavi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Arash Fadavi
Position
Emergency medicine resident
Other areas of specialty/work
Street address
No30,4th Sepehr street,Sepehr street,Marzdaran ave
City
Tehran
Postal code
Phone
+98 21 4429 7136
Fax
Email
arash_fadavi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Dr.Arash Fadavi
Position
Emergency medicine resident
Other areas of specialty/work
Street address
No30,4th Sepehr street,Sepehr street,Marzdaran ave
City
Tehran
Postal code
Phone
+98 21 4429 7136
Fax
Email
arash_fadavi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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