Performance of a new needle system for lumbar punctures in children with blood cancer (leukemia)
| ISRCTN | ISRCTN16161453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16161453 |
| Secondary identifying numbers | IQ-LP-04 |
- Submission date
- 28/06/2022
- Registration date
- 08/07/2022
- Last edited
- 18/04/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Acute lymphoblastic leukemia is the most common type of blood cancer diagnosed in children. At present, the mean long-term survival from this disease is well over 90%. However, the patient's prognosis weakens if the lumbar puncture causes blood leakage into the spinal canal and blast cells enter the cerebrospinal fluid. There is considerable blood leakage in one out of five lumbar punctures in pediatric patients with leukemia on average. In other words, the procedure is considered traumatic.
A new bioimpedance needle system was recently found feasible in lumbar punctures of pediatric patients with leukemia. The device measures electrical resistance at the needle tip and detects when the needle tip reaches the spinal canal. With this device, lumbar punctures were successful at the first attempt in 80% of performed procedures and only one out of ten lumbar punctures was traumatic. The present study compares the performance of the new device with the conventional spinal needle in clinical practice.
Who can participate?
All children with leukemia, whose diagnosis or therapy requires lumbar punctures and who are willing to participate in the study
What does the study involve?
The method used in the patient's first study lumbar puncture is randomly allocated. Thereafter, either a bioimpedance needle system or a conventional spinal needle are alternately used. The maximum number of study procedures per patient is limited to four.
What are the possible benefits and risk of participating?
In the long term, a lower incidence of traumatic lumbar puncture may translate into patients’ improved prognosis and event-free survival. The study is conducted within the usual clinical workflow of pediatric hemato-oncology clinics. Thus, taking part in the study does not require any extra effort from the participant and there are no additional risks of harm or injury.
Where is the study run from?
Tampere University Hospital (Finland)
When is the study starting and how long is it expected to run for?
January 2022 to August 2024
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
1. Dr Sauli Palmu (Finland)
sauli.palmu@tuni.fi
2. Dr Harri Sievänen (Finland)
harri.sievanen@injeq.com
Contact information
Scientific
Injeq Oy
Biokatu 8
Tampere
33520
Finland
 ORCID ID |
0000-0003-3172-248X |
|---|---|
| Phone | +358 (0) 509 100 969 |
| harri.sievanen@injeq.com |
Principal Investigator
Tampere Center for Child
Adolescent and Maternal Health Research
Tampere University Hospital
PO Box 2000
Tampere
33521
Finland
| ORCID ID |
0000-0003-3270-7660 |
|---|---|
| Phone | +358 (0) 3311611 |
| sauli.palmu@tuni.fi |
Study information
| Study design | Multicenter randomized crossover noninferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Success and complications in lumbar punctures of pediatric patients with leukemia: A randomized clinical crossover trial of a bioimpedance needle system versus conventional procedure |
| Study objectives | The performance of the bioimpedance needle system (IQ-Tip system) is at least comparable to the conventional spinal needle regarding the incidence of traumatic lumbar punctures in pediatric hemato-oncology patients |
| Ethics approval(s) | Approved 10/05/2022, Regional Ethics Committee of the Expert Responsibility Area of Tampere University Hospital (TAYS Research Services, PO Box 2000, 33521, Tampere, Finland; +358 50 3295 667; eettinen@pshp.fi), ref: R22039L |
| Health condition(s) or problem(s) studied | Diagnostics and intrathecal treatment of pediatric patients with leukemia |
| Intervention | Patients' lumbar puncture procedures are alternately performed either with the IQ-Tip system (study arm A) or the conventional spinal needle (study arm B). The maximum number of procedures per patient is four and the method of the first procedure is randomly assigned yielding two possible sequences (either ABAB or BABA) |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | 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 | 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 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 |
| Overall study start date | 14/01/2022 |
| Completion date | 31/08/2024 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/05/2023 |
| Date of final enrolment | 31/07/2024 |
Locations
Countries of recruitment
- Finland
Study participating centres
Faculty of Medicine and Health Technology
Teiskontie 35
Tampere
33520
Finland
Department of Pediatric Hematology
Oncology and Stem Cell Transplantation
Stenbäckinkatu 9
Helsinki
00290
Finland
Savitehtaankatu 5
Turku
20520
Finland
Kajaanintie 50
Oulu
90220
Finland
Puijonlaaksontie 2
Kuopio
70210
Finland
Sponsor information
Industry
Biokatu 8
Tampere
33520
Finland
| Phone | +358 (0) 405 805 944 |
|---|---|
| info@injeq.com | |
| Website | https://www.injeq.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal in the field of hemato-oncology |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to reasons pertaining to ethics and data protection of health data of a relatively rare disease |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/07/2023 | 21/07/2023 | Yes | No |
Editorial Notes
18/04/2024: The researchers terminated the study prematurely due to the bankruptcy of the sponsor.
29/08/2023: The plain English summary was updated to reflect the changes of 25/08/2023.
25/08/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2022 to 11/05/2023.
2. The funder Sosiaali- ja Terveysministeriö was removed.
21/07/2023: Publication reference added.
04/07/2022: Trial's existence confirmed by Regional Ethics Committee of the Expert Responsibility Area of Tampere University Hospital.
