Primary thromboprophylaxis in patients with malignancy and central venous catheters: TRIM-Line randomized controlled trial – Design and rationale

Patients with cancer have an increased risk of venous thromboembolism (VTE). This risk is further elevated in those with a central venous catheter (CVC). Although previous studies have shown that prophylactic doses of direct oral anticoagulants (DOACs) are associated with a reduced risk of VTE in ambulatory cancer patients starting chemotherapy, which has led to new recommendations from international clinical guidelines to use DOACs as primary thromboprophylaxis, the same guidelines have not recommended primary thromboprophylaxis for those requiring CVC insertion. As such, the TRIM-Line trial will randomize 1828 patients with active cancer and a newly inserted CVC to rivaroxaban 10 mg daily versus placebo. The primary efficacy outcome is the first objectively confirmed symptomatic or incidental major VTE (proximal upper or lower extremity deep vein thrombosis and/or pulmonary embolism) within 90 days of randomization. The primary safety outcome is major bleeding, as defined by the International Society on Thrombosis and Haemostasis criteria, within 90 days. The key secondary outcomes include clinically relevant non-major bleeding, arterial thrombosis, and overall mortality. The study will provide high-quality evidence to address a key knowledge gap regarding the benefit and risks of thromboprophylaxis in patients with active cancer and an indwelling CVC (NCT05029063).

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Publication Details

Journal
Thrombosis and Haemostasis
Published
2026-09-21
DOI
https://doi.org/10.1055/a-2963-4656
Primary Topic
Venous Thromboembolism Diagnosis and Management
Type
article
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article

Primary thromboprophylaxis in patients with malignancy and central venous catheters: TRIM-Line randomized controlled trial – Design and rationale

Ranjeeta Mallick, Danny Hill, Isabelle Mahé, Aurélien Delluc et al.
Thrombosis and Haemostasis
Venous Thromboembolism Diagnosis and Management
article

Primary thromboprophylaxis in patients with malignancy and central venous catheters: TRIM-Line randomized controlled trial – Design and rationale

Ranjeeta Mallick, Danny Hill, Isabelle Mahé, Aurélien Delluc, Tzu‐Fei Wang, Marcello Di Nisio, Frédéric Larose, P J Kuruvilla, Grégoire Le Gal, Abdulrahman Al Raizah, Marc Carrier, Catherine Sperlich, Steffan Frosi Stella, Chantal Séguin, Alejandro Lazo‐Langner, Bashour Yazji, Vicky Tagalakis, Deborah M. Siegal, Dennis Christopher, Andrea Cervi, Cynthia Wu, Rick Ikesaka, Sudeep Shivakumar, Davide Matino, Walter Ageno, Blair Leonard
article en

Abstract

Patients with cancer have an increased risk of venous thromboembolism (VTE). This risk is further elevated in those with a central venous catheter (CVC). Although previous studies have shown that prophylactic doses of direct oral anticoagulants (DOACs) are associated with a reduced risk of VTE in ambulatory cancer patients starting chemotherapy, which has led to new recommendations from international clinical guidelines to use DOACs as primary thromboprophylaxis, the same guidelines have not recommended primary thromboprophylaxis for those requiring CVC insertion. As such, the TRIM-Line trial will randomize 1828 patients with active cancer and a newly inserted CVC to rivaroxaban 10 mg daily versus placebo. The primary efficacy outcome is the first objectively confirmed symptomatic or incidental major VTE (proximal upper or lower extremity deep vein thrombosis and/or pulmonary embolism) within 90 days of randomization. The primary safety outcome is major bleeding, as defined by the International Society on Thrombosis and Haemostasis criteria, within 90 days. The key secondary outcomes include clinically relevant non-major bleeding, arterial thrombosis, and overall mortality. The study will provide high-quality evidence to address a key knowledge gap regarding the benefit and risks of thromboprophylaxis in patients with active cancer and an indwelling CVC (NCT05029063).

Thrombosis and Haemostasis
Western University (CA), Dalhousie University (CA), University of Padua (IT), University of British Columbia (CA), University of Ottawa (CA), University of Alberta (CA), Université de Bretagne Occidentale (FR), Queen's University (CA), Ottawa Hospital (CA), Jewish General Hospital (CA), Esri (Canada) (CA), Amsterdam UMC Location University of Amsterdam (NL), Niagara Health System (CA), University of Chieti-Pescara (IT), Cégep de Lévis (CA), Windsor Regional Hospital (CA), King Abdullah International Medical Research Center (SA), Assistance Publique – Hôpitaux de Paris (FR), Hôpital Charles-Le Moyne (CA), Sault Area Hospital (CA), William Osler Health System (CA), Ottawa Hospital Research Institute (CA), McGill University (CA), McMaster University (CA)
Good health and well-being
Openalex Percentile: Top 9%
Venous Thromboembolism Diagnosis and Management
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