Clinical trial NCT03420352: Non-Luer Butterfly Needle With One-way Valve for the Epidural Blood Patch: Does it Alter Blood Clotting?
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Dural Puncture Headache
Low Pressure Headache
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Reaction Time (R-time) (Minutes)
timeFrame: 1 hour
measure: Maximum amplitude (millimetre) (MA)
timeFrame: 1 hour
measure: Lysis-30 (%) (LY30)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospital Leicester
Study officials:
affiliation: University Hospital Leicester
name: Asif Mahmood, MBChB,FRCA
role: PRINCIPAL_INVESTIGATOR
References: