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

NCT03420352 | Completed

• 1 other identifier: 196031
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Dural Puncture Headache; Low Pressure Headache

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

butterfly needle with valve

OTHER

thromboelastography

Diagnostic Test: Thromboelastography

Standard hypodermic needle

OTHER

thromboelastography

Diagnostic Test: Thromboelastography

Interventions

Thromboelastography DIAGNOSTIC_TEST

paired TEG analysis undertaken from participants with the two different needles

Standard hypodermic needle; butterfly needle with valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospital Leicester

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Asif Mahmood, MBChB,FRCA

  University Hospital Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 5, 2018
• Study Start: January 1, 2017
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From publication of paper, for as long as required
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.

Locations

GB (1)