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

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.

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache; Low Pressure Headache
• Intervention / Treatment: Diagnostic test: Thromboelastography

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • University Hospital Leicester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: butterfly needle with valve; thromboelastography	Diagnostic test: Thromboelastography; paired TEG analysis undertaken from participants with the two different needles
Other: Standard hypodermic needle; thromboelastography	Diagnostic test: Thromboelastography; paired TEG analysis undertaken from participants with the two different needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospitals, Leicester
• Investigators: Principal Investigator: Asif Mahmood, MBChB,FRCA, University Hospital Leicester

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Embolism and Thrombosis; Headache Disorders; Headache Disorders, Secondary; Headache; Thrombosis; Post-Dural Puncture Headache
• Other Study ID Numbers: 196031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified data with all primary outcomes measures will be made available
• IPD Sharing Time Frame: From publication of paper, for as long as required
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No