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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