Observational findings from two 10-year French studies have shown that fibrinogen below 2.0 g/L has a positive predictive value of 100% for PPH, and a negative predictive value of 79% if concentration is >4.0 g/L . The studies also indicated that the fibrinogen level was associated with the severity of PPH, with adjusted odds ratios of 1.90 for fibrinogen between 2 and 3 g/L and 11.99 for fibrinogen below 2.0 g/L (Fig. 1) .
Data also showed that it was possible to achieve a 60% reduction in bleeding of more than 2500 mL and a fall in the number of hysterectomies required and intensive care unit admissions. From the laboratory perspective, there was a 30% reduction in the use of blood products .
The study’s overall aim was to find ways to improve maternal outcomes by assessing the value of POCT and to investigate the role of fibrinogen as a marker for increasing PPH . Its findings have already led to new risk assessment strategies . These start with the need to make an early, formal risk assessment of every patient, and it recommends that multidisciplinary clinical care is available at the point of care when blood loss reaches 1000 mL.
Patient blood management and POCT
The near-patient testing role in patient blood management (PBM) was one of the issues covered in a recent satellite symposium convened by the Network for the Advancement of Patient Blood Management, Haemostasis and Thrombosis (NATA), supported by iSEP and HemoSonics International, part of global hemostasis experts, Diagnostica Stago.
In a presentation given by Donat Spahn, from the Institute of Anesthesiology, University Hospital of Zürich, Switzerland, the benefits of PBM programmes were discussed, one of which was the use of POCT systems. These have been shown to decrease the use of allogeneic blood transfusion, with its associated costs and adverse events . Identification of these benefits prompted the World Health Organization (WHO) to issue a policy brief in 2021 on the urgent need to implement PBM in all member states .
Aiding rapid decision-making
Clinicians need to know as quickly as possible if fibrinogen products have to be administered to manage coagulopathic bleeds due to hypofibrinogenemia during PPH. There was therefore urgent need for a ‘rapid and reliable’ measurement of functional fibrinogen levels from citrated whole blood.
Crucially, any near-patient solution had to compare well to the gold standard laboratory reference (Clauss) method, as well as being easy to use. In addition, built-in quality control (QC) was required to satisfy laboratory standards for consistency and reproducibility.
The launch of a novel POCT solution (qLabs FIB Monitoring system) has been developed specifically to address these concerns, taking near-patient testing solutions to a new level of accuracy and speed. It measures fibrinogen levels from a single drop of whole blood in ≤10 minutes, with a hands-on time of <60 seconds. Further, the lower a patient’s fibrinogen level, the faster it delivers the result.
The time saved when using this type of innovative point-of-care device compared to the time involved in sending a sample to the laboratory and waiting for a fibrinogen result is significant. Long laboratory turnaround times can result in inappropriate or unnecessary allogeneic blood product transfusion, which may lead to further clinical complications for the patient.
Strong correlation with laboratory testing
In an article by Sanfilippo et al., published earlier this year in the journal Thrombosis Research , Diagnostica Stago’s scientific experts and independent laboratory scientists in France reported on the measurement of fibrinogen concentrations from 110 citrated whole blood specimens, using both the qLabs FIB and the Clauss laboratory reference methods (STA-Liquid Fib assay on STA-R Max; Stago) (Fig. 2).