Venous Thromboembolism, Lung Neoplasm
Conditions
Keywords
Low-molecular-weight Heparin, Tinzaparin
Brief summary
Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.
Detailed description
Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.
Interventions
Subcutaneous tinzaparin 4,500 IU once daily for six months.
Sponsors
Ministry of Health, France
National Cancer Institute, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Social security affiliation * Written informed consent * Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission * D-dimer \> 1,500 µg/L * First line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion * ECOG (Eastern Cooperative Oncology Group) score 0-2 * Life expectancy \>3 months
Exclusion criteria
* Hypersensitivity to heparin or to any excipients * Septic endocarditis * History of heparin-induced thrombocytopenia * Ongoing anticoagulant treatment at therapeutic dosage * VTE at inclusion * Creatinin clearance \<30 mL/min * Active bleeding * Platelet count \< 100 G/L at inclusion * Severe hepatic insufficiency * Cancer treated exclusively with supportive care * Aspirin at daily dosage \> 160 mg * Pregnancy * Patient under tutorship or curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| venous thromboembolic events | 6 months | All venous thromboembolism (VTE) events during the six-month treatment period including: * objectively confirmed symptomatic pulmonary embolism (PE), * objectively confirmed symptomatic lower-limb deep vein thrombosis (DVT) (including iliac and caval thrombosis), * objectively confirmed symptomatic upper extremity DVT, * objectively confirmed incidentally diagnosed PE or proximal DVT * death due to PE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic VTE events | 6 months | Objectively confirmed symptomatic VTE and death due to PE |
| Venous thromboembolic events | 12 months | Objectively confirmed symptomatic or incidental VTE during the 12-months study period |
| Major bleedings | 6 months | Major bleeding according to the ISTH criteria |
| Death | 6 months | Overall mortality and causes of death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Risk factors for venous thromboembolism | 12 months | Risk factors for venous thromboembolism |
Countries
France
Outcome results
None listed