A freeze-dried platelet-derived hemostatic agent improves hemostasis in patients with severe thrombocytopenia before and after standard platelet transfusion: Studies ex vivo in the total thrombus-formation analysis system 01.

BACKGROUND

Lyophilized platelet products have emerged as potential alternatives to standard platelet concentrates (PCs), especially amid shortages or in critical bleeding scenarios. However, assessing their hemostatic efficacy is challenging. The total thrombus-formation analysis system 01 (T-TAS 01), a microfluidic-based technology, provides a standardized approach for evaluating hemostasis in blood samples with low platelet counts.

STUDY DESIGN AND

METHODS

We evaluated the hemostatic performance of a platelet-derived hemostatic product (FPH) using T-TAS 01. FPH was added ex vivo to blood samples from thrombocytopenic oncohematological patients (platelet count <20 × 109/L) collected before (n = 29) and after (n = 18) PC transfusion. T-TAS 01 parameters were: area under the curve (AUC) and occlusion time (OT). The expression of major platelet glycoproteins in FPH was analyzed by flow cytometry.

RESULTS

In pre-transfusion blood, after FPH addition, AUC increased from 33.8 ± 5.4 to 307.0 ± 59.1 (p < .01), and OT shortened from 29.9 ± 0.1 to 23.3 ± 1.5 min (p < .01). In post-transfusion samples, after FPH addition, AUC rose from 85.2 ± 53.9 to 358.6 ± 72.2 (p < .01), while OT decreased significantly from 29.3 ± 0.7 to 21.9 ± 1.8 min (p < .01). These results indicate that platelet transfusions increased AUC, and ex vivo FPH addition may further enhance hemostasis. Glycoproteins' presence in FPH suggests that they may support interactions with the subendothelium and with existing platelets.

DISCUSSION: FPH significantly improved hemostasis in ex vivo samples from thrombocytopenic patients, both before and after PC transfusion, as measured by T-TAS 01. The findings support the potential role of T-TAS 01 in evaluating not only conventional platelet transfusions but also emerging platelet substitutes, such as FPH, for clinical use.