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Comparative study on anticoagulant effect of bivalirudin and heparin in thrombolytic therapy of acute deep venous thrombosis of lower extremities

Comparative study on anticoagulant effect of bivalirudin and heparin in thrombolytic therapy of acute deep venous thrombosis of lower extremities

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068895
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute deep venous thrombosis of lower extremities

Interventions

Treament group:bivarudine
Control group:low molecular weight heparin

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age range: 18-80 years old. It meets the diagnostic criteria of acute iliac, femoral and popliteal vein thrombosis (primary) disease: imaging examination found thrombus formation in deep vein of lower limb. The patients voluntarily participated in the study, signed a written informed consent, and were willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1) Patients who received anticoagulant therapy within the previous 4 weeks; 2) Patients who have had any major surgery or history of severe trauma within 4 weeks prior to the examination; 3) Patients with contraindications or allergies to the use of anticoagulants, contrast agents and thrombolytic drugs had brain, gastrointestinal, etc., in the past 3 months History of active bleeding or cerebral infarction; 4) Patients with high alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were examined At or equal to 1.5 times of the upper limit of normal value stipulated by the Center, or the endogenous creatinine clearance rate (CCr) is greater than the limit of the Center The upper limit of normal values; 5) Total white blood cell count (WBC) was greater than 10.0X109/L or less than 1.0X09/L; 6) The patient has a history of immunodeficiency diseases (such as HIV, etc.), or a history of cancer, malignancy, or autoimmune diseases, or serious cardiovascular or cerebrovascular diseases, or other diseases that may significantly reduce life expectancy; 7) Have a history of any medical conditions that may affect protocol compliance (e.g. severe mental disorder, cognitive impairment, medication) Substance abuse or addiction, etc.); 8) Pregnant or lactating women, or those who are fertile and unwilling/unable to take effective contraceptive measures; 9) Those who are known to be allergic to the ingredients used in this study; 10) Have participated in any drug clinical trials within 6 months before the examination; 11) Patients judged unsuitable for this study by the investigator;

Design outcomes

Primary

MeasureTime frame
thrombolysis rate;diameter of the legs;international normalized ratio;activated partial thromboplastin time;D-Dimer;

Countries

China

Contacts

Public ContactJinsong Wang

Guangdong Provincial People's Hospital

wangjinsong@gdph.org.cn+86 138 2626 6011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026