Deep Vein Thrombosis
Conditions
Keywords
pharmacomechanical thrombectomy
Brief summary
Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).
Detailed description
Acute deep venous thrombosis (DVT) with whole lower limb involved is associated with significant post thrombotic morbidity. Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, ipsilateral popliteal venous the most common access for PMT. However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein. So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.
Interventions
DEVICEpharmacomechanical thrombectomy (PMT)
After randomization patients will be allocated to pharmacomechanical thrombectomy (PMT) via ipsilateral popliteal venous approach or to PMT via distal calf venous approach, bail-out contralateral femoral access can be used if puncture was failed in calf vein. After PMT treatment, residual thrombus was reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) was conducted if there was residual thrombus. Stenosis of iliac vein was assessed by multiangle venography and intravascular ultrasound (IVUS) was used if necessary. Percutaneous balloon angioplasty (PTA) was conducted if there was \>50% stenosis of the diameter of the iliac vein. A stent was placed if the residual stenosis was \>50% after PTA treatment.
Sponsors
First People's Hospital of Hangzhou
The First Affiliated Hospital with Nanjing Medical University
Affiliated Hospital of Nantong University
Chengdu University of Traditional Chinese Medicine
Second Affiliated Hospital of Suzhou University
Liuzhou Workers' Hospital
Shanghai Pudong New Area People's Hospital
Zhejiang University
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18-80 years old; * Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease; * DVT with thrombosis involving the iliac vein, common femoral vein, distal popliteal vein, and/or calf vein; * Informed consent signed by patients.
Exclusion criteria
* Patients with the previous history of the same side of lower-limb DVT; * Patients with plasma Creatinine level greater than 180umol/L; * Patients who are contraindicated to thrombolysis; * Patients with inferior vena cava thrombosis; * Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent; * Patients who have participated in a clinical trial in the past three months; * Women during pregnancy and lactation * Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\<2 years); * Patients with autoimmune thrombopathy or thrombocytopenia (platelets \< 80·10⁹/L); * Patients who are unable or unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-thrombotic syndrome (PTS) | 24 months | Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deep venous valve function evaluation | post-interventional 12 and 24 months | Deep venous valve function evaluation by ultrasound at post-interventional 12 and 24 months |
| European quality of life 5-dimension 5-level (EQ-5D-5L) score | post-interventional 3, 6, 12 and 24 months | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
| Re-intervention rate | within 24 months after operation | Percentage of re-intervention rate within 24 months after operation |
| Rate of catheter-directed thrombolysis | immediately after interventional surgery | Percentage of catheter-directed thrombolysis after mechanical thrombectomy |
| Immediate patency rate | immediately after lonely mechanical thrombectomy | Percentage of patency rate immediately after lonely mechanical thrombectomy |
| Total time of interventional surgery | immediately after interventional surgery | Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis) |
| Total dosage of urokinase | immediately after interventional surgery | Total dosage measured by units of urokinase used for procedure |
| Patency rate of lower limb vein | post-interventional 12 and 24 months | Percentage of patency rate of lower limb vein at post-interventional 12 and 24 months |
| Quality of life evaluated by 36-Item Short Form Health Survey (SF-36) | post-interventional 3, 6, 12 and 24 months | Quality of life evaluated by 36-Item Short Form Health Survey (SF-36). The change in SF-36 Physical and Mental Component Scales from baseline to 24 months will be compared between the two groups using a t-test. A difference of 5 points on each scale is considered to be clinically relevant. In addition, a linear mixed model analysis of the repeated assessments (3, 6, 12, and 24 months) with baseline scores as a covariate will be used to investigate the changes over time, and if they differ by treatment arm. |
| Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score | post-interventional 3, 6, 12 and 24 months | Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score at post-interventional 24 months; The minimum value is 21, and the maximum value is 118. The higher scores mean a better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| all-cause death | Within 24 months after intervention | All-cause death during the follow-up period |
| Safety outcomes - procedural complications | Within 30 days after intervention | Procedural complications such as hematoma at the puncture site, hemoglobinuria or hemolytic jaundice |
| Safety outcomes - major bleeding events | Within 24 months after intervention | Major bleeding events according to the International Society on Thrombosis and Haemostasis (ISTH) |
Countries
China
Contacts
Primary ContactNi Qihong, M.D.
Outcome results
None listed