Serum Blood Clotting Changes During Blood Sampling Via Non-luer One-way Filter Valve Intravenous Needle: Implication on the Epidural Blood Patch Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Maximum amplitude (millimetre) (MA)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
butterfly needle with valve
thromboelastography
干预措施: Thromboelastography (Diagnostic Test)
Standard hypodermic needle
thromboelastography
干预措施: Thromboelastography (Diagnostic Test)
结局指标
主要结局
Maximum amplitude (millimetre) (MA)
时间窗: 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
Lysis-30 (%) (LY30)
时间窗: 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
Reaction Time (R-time) (Minutes)
时间窗: 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
次要结局
未报告次要终点