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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03420352
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Low Pressure Headache Diagnostic Test: Thromboelastography Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arms and Interventions
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Arm Intervention/treatment
butterfly needle with valve
thromboelastography
 Diagnostic Test: Thromboelastography
paired TEG analysis undertaken from participants with the two different needles
Standard hypodermic needle
thromboelastography
 Diagnostic Test: Thromboelastography
paired TEG analysis undertaken from participants with the two different needles


Outcome Measures
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Primary Outcome Measures :
  1. Reaction Time (R-time) (Minutes) [ Time Frame: 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

  2. Maximum amplitude (millimetre) (MA) [ Time Frame: 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

  3. Lysis-30 (%) (LY30) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420352


Locations
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United Kingdom
University Hospital Leicester
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
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Principal Investigator: Asif Mahmood, MBChB,FRCA University Hospital Leicester
  Study Documents (Full-Text)

Documents provided by University Hospitals, Leicester:
Study Protocol and Statistical Analysis Plan  [PDF] January 1, 2017
Informed Consent Form: healthy volunteer consent  [PDF] November 15, 2016
Informed Consent Form: Pregnant volunteer consent  [PDF] July 30, 2016

More Information
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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT03420352    
Other Study ID Numbers: 196031
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data with all primary outcomes measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Thrombosis
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases