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Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome (The TILE Pilot Study): Rationale and Study Protocol

J.P. Galanaud1, J. Abdulrehman2, A. Delluc3, S. Schulman4, S. Kahn5

1Sunnybrook Health Sciences Centre, Medicine, Toronto, Canada, 2University Health Network, Sinai Health System, and Women's College Hospital, Hematology, Toronto, Canada, 3Ottawa Hospital Research Institute, Medicine, Ottawa, Canada, 4Hamilton Health Sciences Centre, Hematology, Hamilton, Canada, 5Jewish General Hospital/McGill University, Medicine, Montreal, Canada

Abstract Number: PB2205

Meeting: ISTH 2020 Congress

Theme: Venous Thromboembolism and Cardioembolism » Post-thrombotic Syndrome

Background: Patients with common femoral or iliac deep-vein thrombosis (DVT) are at very high risk of developing post-thrombotic syndrome (PTS, ≈50%) including moderate to severe PTS (≈28%). Inflammation during the acute phase of DVT plays an important role in the pathophysiology of PTS. Low molecular weight heparins (LMWHs) have anti-inflammatory properties that may hasten acute symptom resolution after DVT and prevent the development of PTS.

Aims: To determine whether an initial 3-week lead-in course of tinzaparin, a LMWH, followed by rivaroxaban, a direct oral anticoagulant (DOAC), is superior to rivaroxaban alone in resolving acute symptoms and preventing PTS in high-risk DVT patients (symptomatic iliac or common femoral DVT).

Methods: A multicenter open-label assessor-blinded pilot randomized controlled trial (RCT) will be conducted 1) to assess study feasibility; and 2) to estimate the magnitude of difference in effectiveness between tinzaparin followed by rivaroxaban vs. rivaroxaban alone to determine the required sample size for a future large, definitive, multicenter RCT. Pilot study design, eligibility criteria and outcomes are shown in Figure 1. For the pilot, 60 patients will be recruited over 18 months at 4 Canadian centres.

Results: The pilot study will be considered successful if >50% of eligible patients agree to participate, and compliance with tinzaparin is >80%. For the definitive RCT, sample size will be based on the pilot study’s results and the primary outcome will be the proportion of patients with PTS at 2 years.

Conclusions: The results of our pilot study will directly inform the feasibility and size of our definitive RCT. Given the health burden, economic burden, and impaired QOL caused by PTS, a non-invasive, safe and time-limited treatment to decrease the risk of PTS and accelerate early symptom resolution is desirable and may be cost-effective and even cost-saving.


[Figure 1: The pilot study design]

To cite this abstract in AMA style:

Galanaud JP, Abdulrehman J, Delluc A, Schulman S, Kahn S. Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome (The TILE Pilot Study): Rationale and Study Protocol [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/tinzaparin-lead-in-to-prevent-the-post-thrombotic-syndrome-the-tile-pilot-study-rationale-and-study-protocol/. Accessed October 1, 2023.

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