Abstract Number: PB0592
Meeting: ISTH 2021 Congress
Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical
Background: While Thrombin Generation (TG) measurement was extensively studied by the international scientific community, and especially in haemophilia, results are so far inconsistent due to poor standardization of TG assays.
The ST Genesia is a fully automated analyzer which provides standardized quantitative measurement of TG in plasma. In association with this instrument, the STG-BleedScreen reagent is a trigger containing low concentration of tissue factor and targets patients with bleeding risk, such as haemophiliacs.
Aims: The study aims at evaluating the ability of TG measured with STG-BleedScreen to discriminate severe Haemophilia A (HA) patients from healthy individuals in a multicentric study.
Methods: A total of 63 severe HA patients and 86 healthy individuals were enrolled on three sites: Cambridge, Vicenza and Barcelona. The study was approved by the local Ethics Committee and all the subjects gave their informed consent prior to enrolment.
Platelet Free Plasma aliquots were prepared from their blood samples and stored for a maximum of 6 months at -70°C prior to analysis on ST Genesia with the STG-BleedScreen. The TG results were compared between HA and healthy groups for absolute and normalized Lag Time (LT), Peak Height (PH) and Endogenous Thrombin Potential (ETP) by using a null hypothesis significance test.
Results: The statistical analysis was performed site by site and by pooling all centers. Table 1 summarizes the mean of each parameter per group.
| Center | LT | PH | ETP | ||||
| Healthy | Severe HA | Healthy | Severe HA | Healthy | Severe HA | ||
| Cambridge | n | 41 | 14 | 41 | 14 | 41 | 14 |
| mean | Abs: 2.72 min Norm: 1.18 |
Abs: 2.66 min Norm: 1.11 |
Abs: 103.60 nM Norm: 66.42% |
Abs: 27.31 nM Norm: 18.19% |
Abs: 741.0 nM.min Norm: 65.81% |
Abs: 331.9 nM.min Norm: 30.14% |
|
| Vicenza | n | 30 | 20 | 30 | 20 | 30 | 20 |
| mean | Abs: 2.57 min Norm: 1.17 |
Abs: 2.18 min Norm: 0.96 |
Abs: 110.15nM Norm: 110.15% |
Abs: 31.31 nM Norm: 22.78% |
Abs: 828.6 nM.min Norm: 80.49% |
Abs: 377.2 nM.min Norm: 37.63% |
|
| Barcelona | n | 15 | 29 | 15 | 29 | 15 | 29 |
| mean | Abs: 3.23 min Norm: 1.11 |
Abs: 2.75 min Norm: 0.94 |
Abs: 128.95 nM Norm: 87.42% |
Abs: 39.00 nM Norm: 27.29% |
Abs: 910.5 nM.min Norm: 84.21% |
Abs: 475.3 nM.min Norm: 43.48% |
|
| All sites | n | 63 | 86 | 63 | 86 | 63 | 86 |
| mean | Abs: 2.76 min Norm: 1.17 |
Abs: 2.55 min Norm: 0.98 |
Abs: 110.30 nM Norm: 72.31% |
Abs: 33.96 nM Norm: 23.83% |
Abs: 801.1 nM.min Norm: 74.14% |
Abs: 412.3 nM.min Norm: 38.66% |
|
Mean LT, PH and ETP parameters (absolute and normalized) for each group and each study site.
LT, PH and ETP were significantly decreased in the haemophiliac population in comparison with the healthy individuals for both absolute and normalized results (p < 0.05). These significant differences were observed on all sites as well as in the multicentric analysis.
Conclusions: The STG-BleedScreen used on the ST Genesia is able to discriminate Severe HA patients from Healthy individuals consistently across clinical laboratories. This opens the door for the system to be used in severe HA patients management.
To cite this abstract in AMA style:
Mullins J, White D, Cox-Morton S, Marin A, Gironella M, Bosch F, Franco S, Tosetto A, Mac Donald S. Assessment of Thrombin Generation on Severe Haemophilia A Patients in the Clinical Laboratory [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/assessment-of-thrombin-generation-on-severe-haemophilia-a-patients-in-the-clinical-laboratory/. Accessed December 8, 2021.« Back to ISTH 2021 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/assessment-of-thrombin-generation-on-severe-haemophilia-a-patients-in-the-clinical-laboratory/