TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol

Area of Science:

• Vascular Medicine
• Clinical Trials
• Pharmacology

Background:

• Post-thrombotic syndrome (PTS) is a chronic venous insufficiency complication following deep venous thrombosis (DVT), affecting 20-50% of patients.
• Current treatment options for established PTS are limited, necessitating effective preventative strategies.
• Low-molecular-weight heparin may offer anti-inflammatory benefits during the acute phase of DVT, potentially reducing PTS risk.

Purpose of the Study:

• To evaluate the feasibility of a larger definitive trial assessing tinzaparin's role in preventing PTS.
• To determine the proportion of patients developing PTS at 6 months using the Villalta scale.
• To assess study feasibility, including patient eligibility, recruitment, and treatment adherence.

Main Methods:

• An investigator-initiated, multicenter, open-label, assessor-blinded pilot trial (NCT04794569).
• Patients with acute symptomatic common femoral or iliac DVT randomized to tinzaparin lead-in followed by rivaroxaban, or rivaroxaban alone.
• Primary outcomes: PTS incidence at 6 months and study feasibility metrics. Secondary outcomes include quality of life, bleeding, and recurrent VTE.

Main Results:

• This section is not applicable as the study is a pilot trial and results are not yet available.

Conclusions:

• This pilot study aims to establish the feasibility of a larger trial investigating novel preventative strategies for post-thrombotic syndrome.
• Findings will inform the design of a definitive study to assess the efficacy of tinzaparin in DVT patients.
• The study will provide insights into the potential of early anti-inflammatory treatment to mitigate long-term complications of DVT.