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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
59
Subcutaneous tinzaparin 4,500 IU once daily for six months.
venous thromboembolic events
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.
Time frame: 6 months
Symptomatic VTE events
Objectively confirmed symptomatic VTE and death due to PE
Time frame: 6 months
Venous thromboembolic events
Objectively confirmed symptomatic or incidental VTE during the 12-months study period
Time frame: 12 months
Major bleedings
Major bleeding according to the ISTH criteria
Time frame: 6 months
Death
Overall mortality and causes of death
Time frame: 6 months
Death
Overall mortality and causes of death
Time frame: 12 months
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Institut de Cancérologie Lucien Neuwirth
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...and 17 more locations