The new Italian registry of infantile thrombosis (RITI): A reflection on its journey, challenges and pitfalls

Abstract

Introduction: Thrombotic events in neonates and children represent a rare although severe occurrence in view of the associated risk of mortality and sequelae. Quality evidence is limited in this field, and registry studies provide an essential base for research. The aim of this paper is to present the new Italian Registry of Infantile Thrombosis (RITI), set it into the scene of international thrombosis and stroke registries, and provide some insight on the challenges associated with registry management.

Methods: We present the detailed structure and content of the new RITI registry, a brief overview of its main data, and a reflection on its features, pitfalls and the main challenges related to its management.

Results: The RITI, initially started in 2007 and officially re-launched in 2017 after structural modifications, is a non-interventional retrospective and prospective registry study collecting data on neonatal and pediatric patients (0-18 years) who experienced a systemic or cerebral thrombotic event in Italy. The RITI is managed by a multidisciplinary team with expertise in pediatric thrombosis, and participation is open to all Italian physicians, on a voluntary basis. The overall aim of the registry is to acquire new evidence to better characterize the population of children with thrombotic events and improve their management and outcome. 48 Italian pediatric and intensive care units are actively involved in the RITI, including 85 medical doctors from 16 Italian regions. A total of 1,001 neonates and children affected by cerebral or systemic thrombosis have been enrolled.

Discussion: The RITI is one of the largest available European registries of neonatal and pediatric thrombosis. National registries like the RITI represent a model for the study of rare conditions based on multidisciplinary and multicenter collaboration, aimed at overcoming the limitations due to small populations of patients, and creating a network of experts for patient referral and continuous education. Moreover, registry studies have a pivotal role in the research on pediatric thrombosis, due to the limited feasibility of high-quality studies. In our experience, the main critical stages, pitfalls and challenges in registry management include adequate registry designing, diffusion, data completeness and quality control.

Keywords: children; neonatal; pediatric; registry; stroke; thromboembolism; thrombosis.

Figure 1

Structure of the data collection form in the RITI registry. The structure of the registry is articulated into sections A (family and past medical history) B (thrombosis-specific questions on risk factors, clinical and radiological presentation, investigations, treatment, clinical and radiological outcome) and C (follow-up data).

Figure 2

Map of Italy, showing the number of enrolled cases for each region. Shades of blue reflect the activity of a specific region. Regions in white are not actively contributing to the RITI registry activity at the present time.

Figure 3

Thrombotic events stratified in three layers. The innermost layer shows the stratification between cerebral thrombotic (gray) and systemic (orange) events can be seen. The middle layer shows the distribution of arterial (red) and venous (blue) events. Finally, in the outermost layer the age stratification is displayed: neonatal events (light blue) and paediatric events (purple).