[Effects of simultaneous use of Cerebrolysin and alteplase on hemorrhagic transformation of brain infarction and functional outcome in stroke patients: CEREHETIS, a randomized, multicenter pilot trial]

What Was Tested

Researchers studied Cerebrolysin in this randomized controlled trial publication.

The study aimed to assess effects of the simultaneous use of Cerebrolysin and intravenous thrombolysis (Alteplase) on hemorrhagic transformation (HT) and functional outcome as well as to analyze the treatment safety in acute stroke patients.

Who Took Part

The Cerebrolysin treatment continued for 14 consecutive days with the baseline therapy along.

Secondary endpoints were treatment safety and functional outcome measured with the National Institutes of Health stroke scale (NIHSS) in 24 h and on day 14, and with the modified Rankin scale (mRS) on day 90.

How the Study Was Run

The design is described as randomized, open-label, multicenter, parallel-group and pilot.

Because people in this Cerebrolysin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Cerebrolysin study: the participants and staff both knew the treatment.

Running at several centres spread the Cerebrolysin study over different clinics and patient groups.

Groups ran in parallel: each of the participants stayed in one arm throughout.

It was a prospective, randomized, open-label, multicenter, parallel-group, active-controlled pilot study (Trial Registration Number: ISRCTN87656744, https://doi.org/10.1186/ISRCTN87656744, Trial registration date: 16/02/2021).

The control group (n=215) received only Alteplase and the baseline therapy.

The primary endpoints were the rate of any and symptomatic hemorrhagic transformation (HT) from admission to day 14.

What Was Measured

Topics PubMed links to this paper include United States, Tissue Plasminogen Activator, Pilot Projects, Stroke, Brain Infarction and Amino Acids.

The authors tagged it with the keywords Cerebrolysin, alteplase, functional outcome, hemorrhagic transformation, ischemic stroke and reperfusion therapy.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Cerebrolysin.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2023 (Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova), a journal based in Russia (Federation).

More context: the Cerebrolysin compound page, all human trials.