Deep vein thrombosis
Conditions
Interventions
rhTNK-tPA thrombolytic therapy group:Thrombolytic measures: a thrombolytic duct is placed during the operation, and 16mg rhTNK-tPA is diluted in 500ml 0.9% normal saline after the operation, and then
At levels below 1.0 g/L, thrombolysis should be stopped.
b) If the platelet count is less than 80×109/L or more than 20% lower than the baseline value, attention should be paid to the increased risk o
When it is lower than 50×109/L, thrombolysis and anticoagulation should be stopped immediately.
c) Monitoring D-dimer: D-dimer can sensitively reflect whether thrombolytic therapy is effective
If the D-dimer continues to increase, thrombolytic therapy can be considered effective. If the D-dimer value decreases from the high value during treatment and gradually tends to normal or maintains a
Sponsors
Sun Yat-sen Memorial hospital, Sun Yat-sen university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Age 18-75, male or female; (2)Onset of symptoms less than 14 days; (3)Diagnosed with DVT in the lower extremity, and venography or ultrasound indicated that the thrombus occurred above the middle thigh; (4)Having good compliance and received diet control and medication; (5)The informed consent is signed by the patient himself or his legal representative
Exclusion criteria
Exclusion criteria: (1)Anticoagulant therapy was received for more than 7 days before enrollment; (2)Patients undergoing iliofemoral vein stenting; (3)Absolute contraindications of thrombolysis exist, including: history of hemorrhagic stroke; Ischemic stroke within 6 months; Central nervous system injury or tumor; Major trauma, surgery, or head injury within the last 3 weeks; Gastrointestinal bleeding within 1 month; (4)Severe liver disease with uncompensated cirrhosis, jaundice, ascites, or hemorrhagic varices; (5)Laboratory test results meet any of the following: 1) Abnormal blood routine: hemoglobin (HGB) 2 times the upper limit of normal (ULN), or glutamate aminotransferase (ALT) >2×ULN, total bilirubin (TBIL) >2×ULN; 3) Abnormal renal function: (estimated GFR 160mmHg or diastolic blood pressure > 100mmHg; (7)Patients with lower extremity DVT during pregnancy or within one week postpartum; (8)Previous ipsilateral proximal DVT formation; (9)Received thrombolytic therapy for lower limb DVT within 7 days prior to inclusion in the trial; (10)Patients with active tumors (progressing or undergoing treatment; (11) Life expectancy is less than 24 months; (12)Participated in other clinical investigators within the last 3 months; (13)Failure to comply with the research protocol; (14)The investigator believes that the subject is at potential risk or that there are any other factors that interfere with the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with Grade III thrombolysis rates;Self-report leg pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of leg circumference diameter;recurrence of VTE;VCSS score;the occurrence of PTS;The quality of life score (SF-36) ;VEINES-QOL score;Non-PTS treatment failure; | — |
Countries
China
Contacts
Public ContactKai Huang
Sun Yat-sen Memorial hospital, Sun Yat-sen university
Outcome results
None listed