Venous Thrombosis
Conditions
Brief summary
The purpose of this study is to determine whether the novel aspiration thrombectomy device combined with catheter-directed thrombolysis is effective in the treatment of acute iliofemoral deep venous thrombosis (IF-DVT).
Detailed description
Catheter-directed thrombolysis will be performed in eligible patients with acute IF-DVT. A combined mechanical thrombectomy will be used to clear the iliac thrombi in experimental group. The immediate, mid- and long-term outcomes will be recorded. Quantitative data wiil be expressed as mean ± SD, and will be compared with independent-sample t-test or paired-sample t-test. Count data will be expressed as a ratio (or percentage), and the chi-square test or the fisher's exact test will be used for comparisons. A difference with P \< 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS, version 22.0 (SPSS Inc., Chicago, IL, USA).
Interventions
DEVICEa manual spiral thrombus broken suction device
A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
PROCEDUREcatheter-directed thrombolysis
catheter-directed thrombolysis will be used in both arms
DRUGlow-molecular-weight heparin calcium
anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge
DRUGurokinase
A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
Sponsors
Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of iliofemoral deep venous thrombosis * Symptoms of less than 14 days' duration * With good function status * A life expectancy of more than 1 year * A low risk of bleeding
Exclusion criteria
* Without iliac vein thrombosis * Anticoagulation and/or thrombolysis contraindications * Systemic infection * Heart, hepatic, renal function insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patency of lower extremity deep venous | up to 36 months | participants will be followed for the duration of hospital stay and will be followed for up to 36 months by lower limb vein color Doppler ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| technical success rate | intraoperation | The ratio of successful and total number of participants |
| thrombus removal rate | intraoperation | The ratio of preoperative and postoperative thrombosis amount |
| improvement of clinical symptoms and signs | up to 36 months | participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations |
| complications | intraoperation | a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture |
| blood loss | intraoperation | The volume of blood loss during operation will be recorded |
Other
| Measure | Time frame | Description |
|---|---|---|
| incidence of postthrombotic syndrome | up to 36 months | participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration |
Countries
China
Outcome results
None listed