Cerebrolysin as an Early Add-on to Reperfusion Therapy: Risk of Hemorrhagic Transformation after Ischemic Stroke (CEREHETIS), a prospective, randomized, multicenter pilot study

What Was Tested

Researchers studied Cerebrolysin in this randomized controlled trial publication.

Cerebrolysin could mitigate reperfusion injury and hemorrhagic transformation (HT) in animal models of acute ischemic stroke.

Who Took Part

The study group was 126 patients.

How the Study Was Run

The researchers set it up as a randomized, open-label, multicenter, parallel-group and pilot study.

Random assignment meant chance, not the researchers, decided who got Cerebrolysin and who got the comparison, which limits bias.

Being open-label, the Cerebrolysin study did not mask who received what.

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

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

This was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study.

The primary outcomes were the rate of any and symptomatic HT assessed from day 0 to 14.

The secondary endpoints were drug safety and functional outcome measured with the National Institutes of Health Stroke Scale (NIHSS) on day 1 and 14, and the modified Rankin scale (mRS) on day 90.

What Was Measured

Topics PubMed links to this paper include Tissue Plasminogen Activator, Stroke, Ischemic Stroke, Pilot Projects, Neuroprotective Agents, Brain Ischemia and Reperfusion.

Author keywords: Cerebrolysin, Hemorrhagic transformation and Reperfusion therapy.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Cerebrolysin in 126 patients.

Its findings take up roughly 8 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 (BMC neurology), a journal based in England.

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