Low Fibrinogen Clinical Trial
Official title:
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
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.
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.
1. Healthy non-pregnant females presenting for elective gynaecology surgery
2. Healthy pregnant females presenting for elective caesarean section
3. Anonymised low fibrinogen adult samples from the laboratory
These 3 populations have been chosen to demonstrate device performance in:
1. Normal non-pregnant fibrinogen concentrations
2. Normal term pregnancy fibrinogen levels
3. Low fibrinogen concentrations By demonstrating equivalent and acceptable performance at
these 3 fibrinogen concentration ranges, we would expect to show performance of the
device to be acceptable for clinical use across the spectrum of patients presenting to
maternity hospitals.
;