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Assessment of Thrombin Generation on Severe Haemophilia A Patients in the Clinical Laboratory

J. Mullins1, D. White1, S. Cox-Morton1, A. Marin2, M. Gironella2, F. Bosch2, S. Franco2, A. Tosetto3, S. Mac Donald1

1Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom, 2Hematology Department of Vall d´Hebrón University Hospital, Barcelona, Spain, 3Hemophilia and Thrombosis Center, Hematology Department, San Bortolo Hospital, Vicenza, Italy

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 October 2, 2023.

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