Comparative analysis of success rate and complications of catheter guided thrombolysis and mechanical trombectomy with Aspirex Device in patients with acute ileofemoral deep vein thrombosis
This study is aimed to compare success rate and complications of catheter guided thrombolysis and mechanical thrombectomy with Aspirex Device in patients with acute ileofemoral DVT. In this clinical trial study, 20 patients aged less than 60 years old with the onset of symptoms less than 2 weeks, referred to Razi hospital in Rasht, and initial diagnosis of acute ileofemoral deep vein thrombosis made by Doppler ultrasound and definite diagnosis made by venography, are included. Patients with heart, renal or pulmonary failure; and the patients with the diagnosis of DVT after two weeks of symptoms’ onset are excluded. In this single blinded study patients are randomly (random numbers) divided to two groups of catheter guided thrombolysis and mechanical thrombectomy with Aspirex Device. Patients’ information including age; sex; underlying disease; affected side; primary symptoms (pain; tenderness; swelling; palor; and …); timeline of the treatment; success rate of the treatment; duration of hospitalization; complications during treatment and hospitalization, complete lysis; improvement of the primary symptoms; and the need of further treatment (stenting or balloon angioplasty), will be recorded in the checklists.
Primary outcomes: Duration of treatment and the success rate of the treatment
Secondary outcoms: Duration of hospitalization, Complication during treatment, Complete thrombolysis, Improvement of the primary symptoms, Complications during hospitalization
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102630508N1
Registration date:2016-12-16, 1395/09/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-16, 1395/09/26
Registrant information
Name
Hosein Hemmati
Name of organization / entity
Vascular surgery and dialysis research center, Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 3354 2460
Email address
hemmati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2016-10-15, 1395/07/24
Expected recruitment end date
2017-10-16, 1396/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative analysis of success rate and complications of catheter guided thrombolysis and mechanical trombectomy with Aspirex Device in patients with acute ileofemoral deep vein thrombosis
Public title
Treating acute ileofemoral DVT by mechanical trombectomy with Aspirex Device
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all the patients aged less than 60 years old with the onset of symptoms less than 2 weeks that initial diagnosis of acute ileofemoral deep vein thrombosis has been made by Doppler ultrasound and definite diagnosis has been made by venography and are a candidate for treatment
Exclusion criteria: patients with heart, renal or pulmonary failure; and the patients with the diagnosis of DVT after two weeks of symptoms onset
Age
To 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized by random number
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite Sepah Bank, Western Shahid Beheshti Blvd., Gaz Square
City
Rasht
Postal code
41448-95655
Approval date
2016-10-15, 1395/07/24
Ethics committee reference number
IR.GUMS.REC.1395.218
Health conditions studied
1
Description of health condition studied
Deep vein thrombosis
ICD-10 code
180.2
ICD-10 code description
Deep vein thrombosis NOS
Primary outcomes
1
Description
Duration of the treatment
Timepoint
During hospitalization
Method of measurement
The time recorded in the checklist
2
Description
The success rate of the treatment
Timepoint
During hospitalization after treatment
Method of measurement
venography
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
During hospitalization
Method of measurement
The time recorded in the checklist
2
Description
Complications during the treatment
Timepoint
During treatment
Method of measurement
Physical examination and Lab tests
3
Description
Complete Thrombus lysis
Timepoint
During hospitalization after treatment
Method of measurement
Venography
4
Description
Improvement of the primary symptoms
Timepoint
During hospitalization, 2 weeks, 1 month, 45 days and 6 manoths after intervention
Method of measurement
Physical examination
5
Description
Complications during hospitalization
Timepoint
During hospitalization
Method of measurement
Physical examination and Lab tests
Intervention groups
1
Description
control goup:
Catheter guided thrombolysis.
Prior to thrombolysis all patients will be given heparin 1000 U/h. PTT will be evaluated and heparin dose will be adjusted based on patient’s PTT.
While the patients are on strict bed rest and anti-coagulation, catheter will be introduced into the thrombus and alteplase infusion will be started with the dose of 1 mg/h.
After 48h a control venography will be performed to evaluate the progress; if there be an underlying stenotic lesion, balloon angioplasty and stenting will be performed as a supplementary procedure.
Category
Treatment - Drugs
2
Description
Intervention group: mechanical thrombectomy with Aspirex Device.Prior to thrombolysis all patients will be given heparin 1000 U/h. PTT will be evaluated and heparin dose will be adjusted based on patient’s PTT.While the patients are on strict bed rest and anti-coagulation, Aspirex Device catheter will be introduced into the lumen and will evacuate the thrombus mass through creating active negative pressure, leading to removal of the thrombus. After 48h, a control venography will be performed to evaluate the progress. If there is an underlying stenotic lesion, balloon angioplasty and stenting will be performed as a supplementary procedure.