Post-Dural Puncture Headache, Low Pressure Headache
Conditions
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
Interventions
DIAGNOSTIC_TESTThromboelastography
paired TEG analysis undertaken from participants with the two different needles
Sponsors
University Hospitals, Leicester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Time (R-time) (Minutes) | 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) | 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) | 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 |
Countries
United Kingdom
Outcome results
None listed