Performance of a new needle system for lumbar punctures in children with blood cancer (leukemia)

Not Applicable

• Conditions: Diagnostics and intrathecal treatment of pediatric patients with leukemia; Not Applicable

• Registration Number: ISRCTN16161453
• Lead Sponsor: Injeq Plc

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37475006/ (added 21/07/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Last Update Posted: 29 April 2024
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Aged between 1 and 18 years old at the beginning of the study
2. Diagnosis or treatment plan requires multiple lumbar puncture procedures for collecting cerebrospinal fluid samples and injecting intrathecal therapy
3. Planned lumbar puncture procedures will be performed with 22G Quincke-type spinal needles
4. At least two lumbar puncture procedures left in the patient’s treatment protocol
5. Both the parent(s) and the patient, depending on the patient’s age, give a signed informed consent before the first study lumbar puncture procedure

Exclusion Criteria

1. Parent(s) and/or the patient refuse to participate in the trial
2. Parent(s) and/or the patient are considered unable to give informed consent
3. Temporary contraindication to performing a lumbar puncture procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of traumatic lumbar puncture measured as the proportion of traumatic lumbar punctures (threshold >/= 10 erythrocytes/µl in a cerebrospinal fluid sample) out of all lumbar puncture procedures performed in the given arm after the data collection of the study is completed

Secondary Outcome Measures

Name	Time	Method
1. First puncture success rate measured as the proportion of successful lumbar puncture procedures at the first attempt (one skin penetration) out of all lumbar puncture procedures performed in the given arm after the data collection of the study is completed<br>2. Incidence of post-dural puncture headache (PDPH) measured as the proportion of lumbar puncture procedures with subsequent PDPH out of all lumbar puncture procedures performed in the given arm after the data collection of the study is completed