Non-Luer Butterfly Needle With One-way Valve for the Epidural Blood Patch: Does it Alter Blood Clotting?

Post-Dural Puncture Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420352
• Other study ID #: 196031
• Status: Completed
• Phase: N/A
• First received: January 19, 2018
• Last updated: February 1, 2018
• Start date: January 1, 2017
• Est. completion date: April 28, 2017

Study information

• Verified date: February 2018
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Low Pressure Headache
• Post-Dural Puncture Headache
• Thrombosis

Intervention

Diagnostic Test:
• Thromboelastography
paired TEG analysis undertaken from participants with the two different needles

Locations

Country	Name	City	State
United Kingdom	University Hospital Leicester	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour
Primary	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	1 hour
Primary	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	1 hour