A Phase 3 interventional study of Tinzaparin Sodium in Venous Thromboembolism and Lung Neoplasm, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 27 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Prevention
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 59 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
usual care,
tinzaparin sodium
Drug: Tinzaparin Sodium
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
Risk factors for venous thromboembolism
Risk factors for venous thromboembolism
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris