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Trial Title: Mechanical Thrombectomy for Acute Lower Limb Deep Vein Thrombosis in Tumor Patients

NCT ID: NCT06085495

Condition: Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT)

Conditions: Official terms:
Thrombosis
Venous Thrombosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Procedure
Intervention name: mechanical thrombectomy (PMT)
Description: After the establishment of the pathway, Angiojet (Boco, USA) was used to infuse urokinase into the blood vessels of the thrombotic segment. After waiting for 15 minutes, mechanical thrombectomy was performed. After thrombectomy, the effectiveness of thrombectomy was evaluated through angiography. For residual thrombi, repeated thrombectomy was performed, with a maximum thrombectomy volume of 480ml. After thrombectomy, antegrade angiography of the dorsal vein of the foot was performed again. If iliac vein stenosis was found to be greater than 50%, Then, Mustang balloons (Boko, USA) that match the normal blood vessel diameter are used for dilation. If the residual stenosis after dilation is greater than 30%, Wallsten stents that match the normal blood vessel diameter are inserted (Boko, USA). After all operations are completed, a dorsalis pedis venography is performed again to evaluate the thrombus burden and calculate the immediate thrombus clearance rate and thrombus clearance level.
Arm group label: Improved approach mechanical thrombectomy (PMT) group

Summary: This study will conduct a prospective single blind controlled study on the clinical efficacy and safety indicators of 50 cancer patients with acute lower limb deep vein thrombosis (DVT). The patients were randomly divided into an experimental group (improved mechanical thrombectomy (PMT) group) and a control group (traditional simple anticoagulation group) using the "envelope method", with 25 cases each. After the end of treatment, clinical prognosis evaluations were conducted on the patient's vital signs, symptoms and signs, lower limb Doppler ultrasound examination, patient PTS score (Villalta score), quality of life score (QOL), etc. at 3, 6, and 12 months. Adverse events, the presence or absence of thrombus recurrence, and re surgical intervention were recorded. This study is expected to propose a new strategy for the treatment of acute DVT in cancer patients, thereby improving the overall level of VTE prevention and treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1) Between the ages of 18 and 75; 2) Suffering from acute lower limb deep vein thrombosis (DVT) with a duration of less than 14 days from onset; 3) Thrombosis involving the iliac vein, femoral vein, or popliteal vein; 4) The patient has been diagnosed with tumors, including benign or malignant tumors, including surgical or conservative treatment; 5) Sign an informed consent form. Exclusion Criteria: - 1) Patients with a history of deep vein thrombosis of the same lower limb in the past; 2) Patients with plasma Cr levels greater than 180umol/L; 3) Patients with contraindications to thrombolytic drugs; 4) Patients with concomitant inferior vena cava thrombosis or simple calf intermuscular vein thrombosis; 5) Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc; 6) Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months; 7) Pregnant and lactating women; 8) Patients with a life expectancy of less than 6 months, or those with other diseases that may cause difficulty in testing or significantly shorten the patient's life expectancy (<1 year), including severe liver disease, cardiac insufficiency, etc; 9) Patients with autoimmune thrombotic disease; 10) Patients who are unable or unwilling to participate in this trial.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Renji Hospital

Address:
City: Shanghai
Zip: 200127
Country: China

Status: Recruiting

Contact:
Last name: Lei Lyu

Phone: 13917427119
Email: wwxxyyzz@263.net

Start date: January 23, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: RenJi Hospital
Agency class: Other

Source: RenJi Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06085495

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