The Bacteria-Associated Thrombosis, Thrombophlebitis and LEmierre syndrome (BATTLE) registry: background and rationale.

Objective Bacteria-associated septic thrombophlebitis and especially its head/neck form, Lemierre syndrome, have been known for over one century but are still associated with considerable fatality and long-term sequelae in children and young adults. Yet, available evidence is limited to case reports or series and is therefore fragmented, susceptible to bias, and inadequate to guide clinical management. To support the development of guidelines and consensus statements, and ultimately improve the care of patients with bacterial thrombophlebitis, we designed the Bacteria-Associated Thrombosis, Thrombophlebitis and LEmierre syndrome (BATTLE) registry.

Material and Methods The BATTLE registry was specifically planned to (i) fill the gaps in amount and quality of evidence on the continuum of Lemierre syndrome (Figure) and bacterial thrombophlebitis by addressing reporting, detection and case-mix bias, and (ii) comply to current international guidelines on quality and standardization of patient registries, including the FAIR framework and the European Commission Joint Research Centre’s recommendations.

Results The BATTLE registry is an independent, investigator-initiated, noninterventionist, multicenter, international, ambispective study. Inclusion criteria are (1) clinically diagnosed or microbiologically documented invasive bacterial infection, (2) history or objective diagnosis of primary infection focus in the head/neck or abdominopelvic district, and (3) thrombosis in location anatomically adjacent to (or embolism consistent with) the primary infection focus (Table). Data entry will be electronic only through the website www.battle-registry.org. The electronic case report form includes the European Commission’s set of common data elements for Rare Disease Registration and covers patient history, clinical course until death or discharge, and long-term follow-up including assessment of functional status and quality of life. The registry has an academic sponsor and its establishment is covered by the Marco Brockhaus award, assigned by the Gesellschaft für Thrombose- und Hämostaseforschung. Ethical approval and registration on ClinicalTrials.gov are pending. Data collection will start in early 2021.

Conclusion The innovative features of the BATTLE registry may effectively contribute to supporting clinical management and research priorities for patients with a group of rare and severe acute thromboembolic disorders.

Fig. 1 The Bacteria-Associated Thrombosis, Thrombophlebitis and LEmierre syndrome (BATTLE) registry: background and rationale – tables and graphs. Figure: Spectrum of Lemierre syndrome in cases described from 2000 to 2017. Table: General inclusion criteria of the BATTLE registry.

Tab 1. General inclusion criteria of the BATTLE registry

Publication History

Article published online:
18 June 2021