LeukemiaSPPLAASHNCT03126045
A Randomized Study Evaluating the Incidence of Post Lumbar Puncture Headache With Atraumatic Needles in Hematology
A study testing Standard needle and Atraumatic needle in people with Leukemia and Lymphoma, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Standard needle and Atraumatic needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Aug 2017to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hematologic syndromes undergoing a diagnostic lumbar puncture
- Signed written informed consent form
- Patient affiliated to a social security regimen or beneficiary of the same
Who cannot join
- Any known contraindication for the lumbar puncture procedure: increased intracranial pressure, blood clotting disorder, thrombocytopenia
- Any known infection
- Patient with a Body Mass index < 18 or Body Mass index > 40
- Any patient that requires an ultrasound guided lumbar puncture
- Patient that underwent a lumbar puncture within 6 months
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
- Refusing participation
- Pregnancy or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Léon Bérard
Lyon, 69000
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology
Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. Some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. In this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.
Read the detailed description
Lumbar punctures (LP) are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache (PLPH) is a common complication in around 30% of patients. PLPH is characterized by the occurrence of a headache with an orthostatic component within 12-72 hours after LP with additional symptoms such as nausea. Even if this phenomenon spontaneously resolves within 3 to 5 days, symptoms can immobilize the patient and can interfere with his daily activities. Technical procedures largely influence the incidence of PLPH. Indeed, some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for PLHP while using atraumatic needles as compared to standard needles. So far, few data are available for hematology. In this context, it is necessary to better document the incidence of PLPH with the use of atraumatic needles in hematologic patients.
- Being tested
- Standard needle, Atraumatic needle
- Keywords
- Lumbar puncture, Post lumbar puncture headache, Atraumatic needle, Haematology
- Medical subject headings
- Leukemia, Lymphoma, Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard needleDevice
Also called BD Yale 405256
Patients will perform a spinal punction with a standard needle, used in the usual practice. The standard needles have the following characteristics : BD 22 G x 3 ½ in, 90mm, Quincke spinal needle, Black hub.
When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture.
Atraumatic needleDevice
Also called Vygon 181.95
Patients will perform a spinal punction with an atraumatic needle, used in the hematological service of the CHU of Saint-Etienne. The atraumatic needles have the following characteristics : Vygon 24 G × 3 ½ in, 90mm, Whitacre Pencil Point Spinal Needle, Purple hub.
When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture.
| Study group | Role | What they receive |
|---|---|---|
| Standard needle | Active comparator | Patients perform a spinal punction according to the usual practice, with a standard needle. Receives: Device: Standard needle |
| Atraumatic needle | Experimental | Patients perform a spinal punction according to the usual practice, with an atraumatic needle. Receives: Device: Atraumatic needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of headache
Incidence of patients with mild and severe headache within 5 days following lumbar puncture as evaluated by verbal rating scales (intensity score ≥4) will be reported.
Measured: 5 days
Secondary outcomes (3)
Intensity of headache
Maximum intensity of headache as evaluated by verbal rating scale (scoring from 0 to 10) within 5 days following lumbar puncture will be reported for each patient.
Measured: 5 days
Duration of significant headache
Duration in days of mild and severe headache (verbal rating scale score ≥ 4) within 5 days following lumbar puncture will be reported for each patient.
Measured: 5 days
Pain intensity
Local and immediate Intensity Pain during lumbar puncture will be reported for each patient. Intensity is evaluated by verbal rating scale.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start22 Aug 2017
- Primary completion20 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: standard needle Arm 2: Atraumatic needle
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Denis Guyotat, PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126045
- Sponsor's protocol ID
- 2017-0302
- Other IDs
- 2017-A00915-48
- Acronym
- SPPLAASH
- Status last verified
- Feb 2022
- First submitted
- 20 Apr 2017
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology
- ClinicalTrials.gov ID
- NCT03126045
- Acronym / sponsor ID
- SPPLAASH / 2017-0302
- Keywords
- Lumbar puncture, Post lumbar puncture headache, Atraumatic needle, Haematology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. Some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. In this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.
Detailed description
Lumbar punctures (LP) are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache (PLPH) is a common complication in around 30% of patients. PLPH is characterized by the occurrence of a headache with an orthostatic component within 12-72 hours after LP with additional symptoms such as nausea. Even if this phenomenon spontaneously resolves within 3 to 5 days, symptoms can immobilize the patient and can interfere with his daily activities. Technical procedures largely influence the incidence of PLPH. Indeed, some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for PLHP while using atraumatic needles as compared to standard needles. So far, few data are available for hematology. In this context, it is necessary to better document the incidence of PLPH with the use of atraumatic needles in hematologic patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: standard needle Arm 2: Atraumatic needle
| Arm | Type | Receives |
|---|---|---|
| Standard needle | Active comparator | Device: Standard needlePatients perform a spinal punction according to the usual practice, with a standard needle. |
| Atraumatic needle | Experimental | Device: Atraumatic needlePatients perform a spinal punction according to the usual practice, with an atraumatic needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hematologic syndromes undergoing a diagnostic lumbar puncture
- Signed written informed consent form
- Patient affiliated to a social security regimen or beneficiary of the same
Key exclusion criteria (8 listed)
- Any known contraindication for the lumbar puncture procedure: increased intracranial pressure, blood clotting disorder, thrombocytopenia
- Any known infection
- Patient with a Body Mass index < 18 or Body Mass index > 40
- Any patient that requires an ultrasound guided lumbar puncture
- Patient that underwent a lumbar puncture within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard needleAlso: BD Yale 405256Patients will perform a spinal punction with a standard needle, used in the usual practice. The standard needles have the following characteristics : BD 22 G x 3 ½ in, 90mm, Quincke spinal needle, Black hub. When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture. | Device | Standard needle |
| Atraumatic needleAlso: Vygon 181.95Patients will perform a spinal punction with an atraumatic needle, used in the hematological service of the CHU of Saint-Etienne. The atraumatic needles have the following characteristics : Vygon 24 G × 3 ½ in, 90mm, Whitacre Pencil Point Spinal Needle, Purple hub. When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture. | Device | Atraumatic needle |
Primary outcome
Number of headache
Time frame: 5 days
Incidence of patients with mild and severe headache within 5 days following lumbar puncture as evaluated by verbal rating scales (intensity score ≥4) will be reported.
3 secondary outcomes
Intensity of headache
Time frame: 5 days
Duration of significant headache
Time frame: 5 days
Pain intensity
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Guyotat, PhD principal investigator
CHU de Saint-Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard needle and Atraumatic needle in people with Leukemia and Lymphoma, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of headache (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.