Sievänen, H., Kari, J., Aarnivala, H. et al. Success and complications in lumbar punctures of pediatric patients with leukemia: a study protocol for a randomized clinical crossover trial of a bioimpedance needle system versus conventional procedure. Trials 24, 464 (2023). https://doi.org/10.1186/s13063-023-07498-4
Success and complications in lumbar punctures of pediatric patients with leukemia : a study protocol for a randomized clinical crossover trial of a bioimpedance needle system versus conventional procedure
|Author:||Sievänen, Harri1; Kari, Juho1; Aarnivala, Henri2;|
1Injeq Plc, Tampere, Finland
2Department of Pediatric Hematology and Oncology, Oulu University Hospital, Oulu, Finland
3Department of Pediatric Hematology and Oncology, Kuopio University Hospital, Kuopio, Finland
4Department of Pediatric and Adolescent Hematology and Oncology, Turku University Hospital, Turku, Finland
5Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, New Children’s Hospital, Helsinki University Hospital, Helsinki, Finland
6Tampere Center for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University and Tampere University Hospital, Tampere, Finland
|Online Access:||PDF Full Text (PDF, 1.3 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe20231013139997
|Publish Date:|| 2023-10-13
Background: Acute lymphoblastic leukemia (ALL) is the most common malignancy diagnosed in children. At present, the long-term survival from pediatric ALL is well over 90%. However, the probability of event-free survival is reduced if the lumbar puncture (LP) procedures at the beginning of the patient’s intrathecal therapy cause blood leakage into the spinal canal and blast cells contaminate the cerebrospinal fluid. According to the literature, such traumatic LP procedures concern one out of five pediatric patients with ALL.
Recently, a novel medical device measuring the tissue bioimpedance at the tip of a spinal needle was found feasible in pediatric patients with ALL. The LP procedure was successful at the first attempt in 80% of procedures, and the incidence of traumatic LPs was then 11%. The purpose of the present study is to compare the bioimpedance spinal needle system with the standard clinical practice resting on a conventional spinal needle and investigate its efficacy in clinical practice.
Methods: The study is a multicenter, randomized, two-arm crossover noninferiority trial of pediatric hemato-oncology patients that will be conducted within the usual clinical workflow. Patients’ LP procedures will be performed alternately either with the IQ-Tip system (study arm A) or a conventional Quincke-type 22G spinal needle (study arm B). For each enrolled patient, the order of procedures is randomly assigned either as ABAB or BABA. The total number of LP procedures will be at least 300, and the number of procedures per patient between two and four. After each study LP procedure, the performance will be recorded immediately, and 1-week diary-based and 4-week record-based follow-ups on symptoms, complications, and adverse events will be conducted thereafter. The main outcomes are the incidence of traumatic LP, first puncture success rate, and incidence of post-dural puncture headache.
Discussion: The present study will provide sound scientific evidence on the clinical benefit, performance, and safety of the novel bioimpedance spinal needle compared with the standard clinical practice of using conventional spinal needles in the LP procedures of pediatric patients with leukemia.
Trial registration: ISRCTN ISRCTN16161453. Registered on 8 July 2022.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3123 Gynaecology and paediatrics
Open access funding provided by Tampere University including Tampere University Hospital, Tampere University of Applied Sciences (TUNI). The trial is mainly funded by the research grants of the principal investigator. Additional research funding will be applied as appropriate. The study sponsor Injeq Plc provides the IQ-Tip systems, including the IQ-Tip spinal needles and cables, needed for the study. It will also provide human resources for data and statistical analysis, monitoring, and scientific writing.
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