Comparison of early discharge from emergency department and inpatient management of lower extremity DVT about cost and prevalence of secondary infection, gastrointestinal bleeding and pulmonary embolism.
The aim of this study is comparison of early discharge from emergency department and inpatient management of lower extremity deep vein thrombosis about cost and prevalence of secondary infection, gastrointestinal bleeding and pulmonary embolism. All patients with thrombosis of the lower extremities will be enrolled in this study. Patients with a previous history of thrombosis, previous use of anticoagulants, contraindication of heparin and warfarin, hemodynamic instability and conditions unsuitable to receive treatment at home will be excluded. 120 patients will be enrolled in this study. Patients will be divided to groups. Group one will be admitted to hospital and Group two will be managed outpatient. At all patients the treatment is similar and will be enoxaparin 60 mg/kg/BD and warfarin 5 mg daily. INR will be measured first day and 3 and 5 days after beginning of treatment. When INR reached 2, the enoxaparin will be cut. The cost of treatment at 2 groups will be compared. All patients will be assessed for side effect such as infection, death and Gastrointestinal bleeding during one month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060517812N2
Registration date:2014-08-22, 1393/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-22, 1393/05/31
Registrant information
Name
Gholamreza Faridaalaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 9540
Email address
faridaalaee@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early discharge from emergency department and inpatient management of lower extremity DVT about cost and prevalence of secondary infection, gastrointestinal bleeding and pulmonary embolism.
Public title
Comparison of advantage and disadvantage of early discharge from emergency department and inpatient management of lower extremity DVT: RCT
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: all lower extremity deep vein thrombosis patients
exclusion criteria: previous thrombosis; previous use of anticoagulants; contraindication of of heparin and warfarin; hemodynamic instability
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Scinces
Street address
Urmia University of Medical Scinces; Resalat Avenue
City
Urmia
Postal code
Approval date
2014-05-20, 1393/02/30
Ethics committee reference number
umsu.rec.1393.67
Health conditions studied
1
Description of health condition studied
Lower Extermity Deep Vein Thrombosis
ICD-10 code
I 80.3
ICD-10 code description
Phlebitis and thrombophlebitis of lower extremities, unspecified
2
Description of health condition studied
Lower Extermity Deep Vein Thrombosis
ICD-10 code
I80.1
ICD-10 code description
Phlebitis and thrombophlebitis of femoral vein
3
Description of health condition studied
Lower Extermity Deep Vein Thrombosis
ICD-10 code
I 80.2
ICD-10 code description
Phlebitis and thrombophlebitis of other deep vessels of lower extremities
Primary outcomes
1
Description
secundery infection
Timepoint
after 3 days, 5 days and 30 days
Method of measurement
history and physical examination
2
Description
pulmonary emboli
Timepoint
after 3 days, 5 days and 30 days
Method of measurement
history and physical examination
Secondary outcomes
1
Description
Gastrointestinal bleeding
Timepoint
after 3 days, 5 days and 30 days
Method of measurement
history and physical examination
2
Description
death
Timepoint
at all time of study up to 1 month
Method of measurement
physical examination
Intervention groups
1
Description
Group control will be admitted to hospital and treatment will be administered in hospital .
Category
Other
2
Description
In intervention group, treatment will be administered out patiently.