A Clinical Study to Define Precision, Accuracy, and Comparability of Results From a Novel Point of Care Fibrinogen Assay (F-Point), Compared to an Industry Standard
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Measurement of Fibrinogen concentration
研究概览
简要总结
The F-Point investigation is an open label, single centre prospective observational study in 3 cohorts of patients, one with low fibrinogen concentration, one with normal fibrinogen concentration, and one with high fibrinogen concentration To show statistical agreement between the fibrinogen level as recorded by the standard lab Clauss fibrinogen, and the fibrinogen level as recorded by the novel F-Point device.
详细描述
The area to be investigated is the measurement of blood fibrinogen concentration. The aim is to develop a device which can give a fibrinogen level rapidly and accurately, in order to allow decision making quickly in emergency haemorrhage situations.
Postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity throughout the world and is accountable for 27.1% of maternal deaths worldwide according to a recent WHO systematic analysis.1 The confidential enquiry into maternal deaths and morbidity 2012 - 2014 describes 13 deaths from maternal haemorrhage.2 Fibrinogen is an component of the coagulation cascade. It is the principal factor for the final stage of clot formation. The fibrinogen level increases during pregnancy from the first through to third trimester.3 During a PPH this level decreases rapidly, influenced by two principal mechanisms, the loss of the blood itself and the consumption of coagulation factors associated with coagulation activation. Fibrinogen level below 2g/L in the early phase of PPH correlates with subsequent development of severe PPH.4 The conventional laboratory tests (Clauss, PT-derived) are time consuming, and workload intensive for laboratory staff. This has implications in terms of decision making in a rapidly changing clinical environment during a massive PPH. A point of care test, with more rapidly available results at the patient location should improve the speed of decision making based on individual patient data. The focus of this study is to validate the fibrinogen concentration as measured by the F-point device compared to the laboratory standard Clauss fibrinogen. The F-Point is second generation POC device that is compatible with deployment within the emergency room or operating theater. By having rapid access to fibrinogen concentration results, early and individualized treatment can be implemented with the aim of improving patient outcomes, with a possible decrease in unnecessary administration of fibrinogen.
We aim to show equivalent performance between the F-Point device in 3 populations.
- Healthy non-pregnant females presenting for elective gynaecology surgery
- Healthy pregnant females presenting for elective caesarean section
- Anonymised low fibrinogen adult samples from the laboratory
These 3 populations have been chosen to demonstrate device performance in:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the clinical investigation.
- •Female, aged 18 years or above.
- •Able (in the Investigators opinion) and willing to comply with all clinical investigation requirements.
- •Presenting for Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure
- •Group 3 will consist of anonymous patient samples
排除标准
- •Patients on any antiplatelet or anticoagulant medications
- •o Patients prescribed subcutaneous low molecular weight heparin medications are permitted to enrol, provided the timing of sampling is outside of 24 hours after the last dose of the medication.
- •Any patient with a known thrombophilia or a known haemophilia.
- •Any patient with a known dysfibrinogenaemia except in the anonymous low fibrinogen group
- •Patients with a known malignancy or autoimmune condition affecting blood clotting
- •A personal history of easy bruising strongly suggestive of a blood clotting disorder
- •Any reason, in the opinion of the investigator that would make the subject unsuitable for participation
结局指标
主要结局
Measurement of Fibrinogen concentration
时间窗: Within 2 hours of blood drawn
To demonstrate equivalent performance between a novel point of care device, the F-point, when compared to the laboratory Clauss assay for measuring fibrinogen concentration.
次要结局
未报告次要终点