Deep Vein Thrombosis, Pharmacomechanical Thrombolysis
Conditions
Keywords
Pharmacomechanical thrombolysis, Deep vein thrombosis, post-thromboticsyndrome
Brief summary
This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.
Detailed description
Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.
Interventions
PROCEDUREPharmacomechanical thrombolysis
Pharmacomechanical thrombolysis
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)； 2. Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ; 3. Obtain the informed consent of all patients.
Exclusion criteria
1. Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ; 2. patients who are prohibited from thrombolytic therapy; 3. inferior vena cava compression syndrome； 4. Allergic to heparin, low molecular weight heparin or contrast medium; 5. Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months; 6. Patients who do not want to participate in this trial; 7. Patients with poor compliance, or those who the researchers think are not suitable for selection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower extremity deep vein patency rate 6 months after operation | 6 months | The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. |
| Incidence of sequelae of deep venous thrombosis after PMT | 24 months | According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower extremity deep venous patency rate of patients before discharge | 1 week | The patency rate of lower extremity deep veins in patients 1 week after operation |
| Postoperative quality of life score (QOL) | 6 months,12 months,18 months and 24 months | Postoperative quality of life scoring using the QOL scale |
| Total duration of interventional treatment | 1 day | Including the entire operation time of interventional surgery |
| Incidence of bleeding complications | 1day，7day，3 months | Symptoms of perioperative hemorrhage |
| reoperation rate | 6 months,12 months,18 months and 24 months | Reoperation due to thrombosis, pts |
| Total urokinase dosage | 1 day | interventional surgery urokinase dosage |
Countries
China
Contacts
Primary ContactChunshui He, doctor
Backup ContactWei Huang, master
Outcome results
None listed