Treatment of acute hemispheric cerebral infarction with the combination of thrombolysis and hemodilution : doctoral thesis

Ciljevi istraživanja: Procijeniti učinkovitos, ishod i sigurnost liječenja bolesnika s akutnim ishemijskim moždanim udarom primjenom rekombiniranog tkivnog aktivatora plazminogena (rt-PA) te hemodilucije koja slijedi trombolizu. Ispitanici i metode: Unutar 3 sata od nastupa simptoma akutnog ishemijskog moždanog udara, 71 bolesnik je primio rt-PA (0,9 mg / kg). Sat vremena nakon trombolize započeta je hemodilucija dextranom 40 u trajnoj i.v. infziji. Ishod je uspoređivan s ishodom liječenja 71 bolesnika koji su primili samo hemodiluciju. Primarno je procijenjen neurološki oporavak, te smrtnost tijekom tromjesečnog praćenja. Analizirana je učestalost simptomatskih unutarmoždanih krvarenja. Rezultati: Bolesnici liječeni s rt-PA imali su bolji ishod liječenja u usporedbi s kontrolnom skupinom (64,79% naspram 22,54%; p = 0,0001). Također, značajno je veći broj bolesnika u ispitivanoj skupini imao potpuni oporavak neurološkog deficita ili je zaostao minorni deficit. Liječenja s rt-PA značajno je reduciralo smrtnost unutar 90 dana (1,41% naspram 18,31%; p = 0,002). Unutar ispitivane skupine simtomatsko unutarmoždano krvarenje zabilježeno je u 1 ispitanika koji se oporavio do stupnja funkcionalne samostalnosti, a asimptomatsko krvarenje je zabilježeno u 2 bolesnika. Zaključak: U bolesnika s akutnim ishemijskim moždanim udarom, liječenje primjenom rt-PA i hemodilucije značajno pridonosi neurološkom oporavku. Ova pilot sudija može biti osnova za buduće randomizirane studije koje bi uspostavile smjernice primjene ovakovog liječenja.Objectives: To evaluate safety, clinical feasibility, and outcome of thrombolysis treatment with recombinant tissue plasminogen activator (rt-PA) followed by hemodilution in patients with ischemic stroke. Patients and Methods: 71 patients presenting with ischemic stroke within 3 hours of onset of symptoms were given intravenous rt-PA (0,9 mg / kg total dose) followed by hemodilution treatment that started one hour after thrombolysis and was achieved by infusion of dextran 40. Those patients were compared to 71 patients treated with hemodilution only. Main outcome measures were neurologic recovery and mortality at a 3-month follow-up. Also, the incidence of symptomatic intracerebral hemorrhage (ICH) was analyzed. Results: Patients treated with rt-PA had a favorable outcome than the control group (64,79% vs. 22,54%; p = 0,0001). Also, the greater proportion of patients left with minimal or no deficit 90 days after rt-PA treatment, as compared with the control group. Treatment with rt-PA significantly reduce mortality in 90 days (1,41% vs.18,31%; p = 0,002). In the rt-PA treated group symptomatic intracranial hemorrhage occurred in 1 patient who recovered to a level of functional independence and asymptomatic intracranial hemorrhage was observed in 2 patients. Conclusion: Our results revealed improvement of neurological deficit in acute ischemic stroke patients treated with rt-PA followed by hemodilution. This pilot study shows that it may be associated with better outcomes but further studies and clinical randomized trials are needed to establish indications and administration protocols