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

Primary Purpose

Post-Dural Puncture Headache, Low Pressure Headache

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Thromboelastography
Sponsored by
University Hospitals, Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Dural Puncture Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Leicester

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

butterfly needle with valve

Standard hypodermic needle

Arm Description

thromboelastography

thromboelastography

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 19, 2018
Last Updated
February 1, 2018
Sponsor
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT03420352
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache, Low Pressure Headache

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
butterfly needle with valve
Arm Type
Other
Arm Description
thromboelastography
Arm Title
Standard hypodermic needle
Arm Type
Other
Arm Description
thromboelastography
Intervention Type
Diagnostic Test
Intervention Name(s)
Thromboelastography
Intervention Description
paired TEG analysis undertaken from participants with the two different needles
Primary Outcome Measure Information:
Title
Reaction Time (R-time) (Minutes)
Description
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the R-time
Time Frame
1 hour
Title
Maximum amplitude (millimetre) (MA)
Description
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the MA
Time Frame
1 hour
Title
Lysis-30 (%) (LY30)
Description
We will measure the thromboelastography (TEG) results of the patients blood with each needle. The TEG analysis will provide us with the LY30
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asif Mahmood, MBChB,FRCA
Organizational Affiliation
University Hospital Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Leicester
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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