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Completed

NCT Number: NCT03420352

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Leicester

Leicester, LE1 5WW, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thromboelastography

Diagnostic Test

paired TEG analysis undertaken from participants with the two different needles

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study title

Serum Blood Clotting Changes During Blood Sampling Via Non-luer One-way Filter Valve Intravenous Needle: Implication on the Epidural Blood Patch Procedure

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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