Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
- Registration Number
- NCT03090880
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Tinzaparin Sodium tinzaparin sodium
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Venous thromboembolic events 12 months Objectively confirmed symptomatic or incidental VTE during the 12-months study period
Symptomatic VTE events 6 months Objectively confirmed symptomatic VTE and death due to PE
Major bleedings 6 months Major bleeding according to the ISTH criteria
Death 12 months Overall mortality and causes of death
Trial Locations
- Locations (27)
Hôpital Pontchaillou
🇫🇷Rennes, Bretagne, France
Centre Hospitalier régional d'Orléans
🇫🇷Orléans, Centre, France
Centre Oscar Lambret
🇫🇷Lille, Hauts De France, France
Hôpital Avicenne, Hôpitaux universitaires Paris Seine-
🇫🇷Bobigny, Ile De France, France
Hôpital d'Instruction des Armées Percy
🇫🇷Clamart, Ile De France, France
Hôpital Louis Mourier
🇫🇷Colombes, Ile De France, France
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, Ile De France, France
Centre Hospitalier de Versailles André Mignot
🇫🇷Le Chesnay, Ile De France, France
Hôpital Bicêtre
🇫🇷Le Kremlin Bicêtre, Ile De France, France
Institut Curie
🇫🇷Paris, Ile De France, France
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