NCT03090880

Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Lung Neoplasm

Interventions

Type	Name	Description
DRUG	Tinzaparin Sodium	Subcutaneous tinzaparin 4,500 IU once daily for six months.

Timeline

• Start date: 2018-09-14
• Primary completion: 2021-08-18
• Completion: 2021-08-18
• First posted: 2017-03-27
• Last updated: 2022-11-17

Locations

27 sites across 1 country: France