Post-Dural Puncture HeadacheNCT03420352
Non-Luer Butterfly Needle With One-way Valve for the Epidural Blood Patch: Does it Alter Blood Clotting?
A study testing Thromboelastography in people with Post-Dural Puncture Headache and Low Pressure Headache, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The Department of Health recommends using equipment which prevents wrong route drug administration. However, the epidural blood patch requires equipment that connects to the intravenous and epidural route. To comply with these recommendations a non-Luer butterfly needle with one-way valve has been produced. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache, Low Pressure Headache
- What is being tested?
- Thromboelastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2017to 28 Apr 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female.
- Aged 18 years or above.
- Within first 2 days postnatal for postnatal group
- Healthy participants must be in good health.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Any medical condition
- In postnatal group, women with haemorrhage greater than 1L
- In postnatal group, less than 12 hours post prophylactic dalteparin
- Any clotting abnormality
- On any medication including herbal medication (vitamins taken during pregnancy are acceptable)
- Age less than 18 years at recruitment
Show all 16Show fewer
- Adults who are not capable of giving valid consent
- Adults with learning disabilities/ difficulties
- Adults in emergency situations
- Unable to speak or read English
- Prisoners
- Adults unable to consent for themselves
- Any person considered to have a particularly dependent relationship with investigators
- Any others deemed to belong to a vulnerable group.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Blood Clotting Changes During Blood Sampling Via Non-luer One-way Filter Valve Intravenous Needle: Implication on the Epidural Blood Patch Procedure
The Department of Health recommends using equipment which prevents wrong route drug administration. However, the epidural blood patch requires equipment that connects to the intravenous and epidural route. To comply with these recommendations a non-Luer butterfly needle with one-way valve has been produced. The one-way valve and length of tubing has the potential to activate the clotting cascade. This could reduce the time clinicians have to utilise the blood in the syringe. Also any alteration in clotting could affect the therapeutic value of the epidural blood patch. The primary objective of this research was to determine if phlebotomy using this new 21G needle altered blood clotting, determined by thromboelastograph analysis, compared to a standard 21G hypodermic needle.
Read the detailed description
Ethical approval was gained from the Health Research Authority (North West - Greater Manchester South Research Ethics Committee, REC Reference Number: 16/NW/0570). After informed consent, we enrolled participants
- Being tested
- Thromboelastography
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDiagnostic test
paired TEG analysis undertaken from participants with the two different needles
| Study group | Role | What they receive |
|---|---|---|
| butterfly needle with valve | Other | thromboelastography Receives: Diagnostic Test: Thromboelastography |
| Standard hypodermic needle | Other | thromboelastography Receives: Diagnostic Test: Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time (R-time) (Minutes)
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the R-time
Measured: 1 hour
Maximum amplitude (millimetre) (MA)
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the MA
Measured: 1 hour
Lysis-30 (%) (LY30)
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the LY30
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jan 2017
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asif Mahmood, MBChB,FRCA, Principal investigator, University Hospital Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420352
- Sponsor's protocol ID
- 196031
- Status last verified
- Feb 2018
- First submitted
- 19 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data with all primary outcomes measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Blood Clotting Changes During Blood Sampling Via Non-luer One-way Filter Valve Intravenous Needle: Implication on the Epidural Blood Patch Procedure
- ClinicalTrials.gov ID
- NCT03420352
- Acronym / sponsor ID
- 196031
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 5 Feb 2018 (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.
The Department of Health recommends using equipment which prevents wrong route drug administration. However, the epidural blood patch requires equipment that connects to the intravenous and epidural route. To comply with these recommendations a non-Luer butterfly needle with one-way valve has been produced. The one-way valve and length of tubing has the potential to activate the clotting cascade. This could reduce the time clinicians have to utilise the blood in the syringe. Also any alteration in clotting could affect the therapeutic value of the epidural blood patch. The primary objective of this research was to determine if phlebotomy using this new 21G needle altered blood clotting, determined by thromboelastograph analysis, compared to a standard 21G hypodermic needle.
Detailed description
Ethical approval was gained from the Health Research Authority (North West - Greater Manchester South Research Ethics Committee, REC Reference Number: 16/NW/0570). After informed consent, we enrolled participants
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| butterfly needle with valve | Other | Diagnostic Test: Thromboelastographythromboelastography |
| Standard hypodermic needle | Other | Diagnostic Test: Thromboelastographythromboelastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female.
- Aged 18 years or above.
- Within first 2 days postnatal for postnatal group
- Healthy participants must be in good health.
Key exclusion criteria (16 listed)
- Any medical condition
- In postnatal group, women with haemorrhage greater than 1L
- In postnatal group, less than 12 hours post prophylactic dalteparin
- Any clotting abnormality
- On any medication including herbal medication (vitamins taken during pregnancy are acceptable)
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 |
|---|---|---|
| Thromboelastographypaired TEG analysis undertaken from participants with the two different needles | Diagnostic test | Standard hypodermic needle, butterfly needle with valve |
Primary outcome
Reaction Time (R-time) (Minutes)
Time frame: 1 hour
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the R-time
Maximum amplitude (millimetre) (MA)
Time frame: 1 hour
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the MA
Lysis-30 (%) (LY30)
Time frame: 1 hour
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the LY30
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 5 Feb 2018.
- Individual participant dataSharing planned: Yes. De-identified data with all primary outcomes measures will be made available
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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.
Asif Mahmood, MBChB,FRCA principal investigator
University Hospital Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastography in people with Post-Dural Puncture Headache and Low Pressure Headache, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 7 inclusion and 16 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Reaction Time (R-time) (Minutes) (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 5 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.