Abstract Background and aims Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA) is an effective treatment for acute ischemic stroke (AIS), but intracranial hemorrhage (ICH) remains a major complication. Reliable prediction of therapy-associated ICH at treatment initiation is lacking. This prospective observational study investigated whether rotational thromboelastometry (ROTEM) can predict the safety and outcome of thrombolysis, and whether assay modification improves its predictive value. Methods Blood samples were collected from 114 AIS patients before and immediately after intravenous rt-PA administration. ROTEM was performed at both timepoints using citrated whole blood in a ROTEM SIGMA device. To mimick the in vivo effect of rt-PA, the test was also performed in the presence of 140 ng/mL rt-PA (mROTEM-t-PA) added directly to pre-thrombolysis samples. Therapy-associated ICH was classified according to ECASSII. Short-term outcome was assessed by NIHSS change on day 7 relative to admission. Long-term outcomes were defined at 3 months post-event by the modified Rankin Scale. Results The mROTEM-tPA assay correlated strongly with both pre- and post-thrombolysis ROTEM clot formation parameters, indicating reliable modeling of rt-PA effects. Higher pre-thrombolysis clot firmness (A5, MCF) was associated with more severe stroke. Pre-thrombolysis EXTEM A5 demonstrated modest predictive value for unfavorable short-term outcome (AUC=0.64, p=0.022). No standard ROTEM parameter predicted 90-day functional outcome or ICH. The mROTEM-tPA EXTEM LI60 strongly predicted ICH, as all cases showed complete clot lysis (LI60=0%). An LI60 0% excluded post-lysis ICH with 100% sensitivity and negative predictive value (p=0.038). Conclusions These results suggest that modified ROTEM testing may help exclude thrombolysis-associated ICH using pre-treatment samples. Conflict of interest István Szegedi: nothing to disclose. Rita Orbán-Kálmándi: nothing to disclose. Dóra Bomberák: nothing to disclose. Linda Lóczi: nothing to disclose. Tamás Árokszállási: nothing to disclose. László Oláh: nothing to disclose. László Csiba: nothing to disclose. Zsuzsa Bagoly: nothing to disclose.
Szegedi et al. (Fri,) studied this question.