Systemic and cerebro-cardiac biomarkers following traumatic brain injury: an interim analysis of randomized controlled clinical trial of early administration of beta blockers.

What Was Tested

Researchers studied Cerebrolysin in this randomized controlled trial publication.

This is an interim analysis of the Beta-blocker (Propranolol) use in traumatic brain injury (TBI) based on the high-sensitive troponin status (BBTBBT) study.

The BBTBBT is an ongoing double-blind placebo-controlled randomized clinical trial with a target sample size of 771 patients with TBI.

Who Took Part

The study group was 771 patients.

PubMed indexes the participants as adults and middle-aged adults, both men and women.

Patients with positive HsTnT (non-randomized) received propranolol (Group-1; n = 110), and those with negative test were randomized to receive propranolol (Group-2; n = 129) or placebo (Group-3; n = 111).

Three hundred and fifty patients with comparable age (mean 34.8 ± 9.9 years) and gender were enrolled in the interim analysis.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

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.

Neither the patients nor the staff measuring them knew who was on Cerebrolysin, so expectations could not easily colour the readings.

Some patients received a placebo instead of Cerebrolysin, giving a reference point.

What Was Measured

Luminex and ELISA-based immunoassays were used to quantify the serum levels of pro-inflammatory cytokines (Interleukin (IL)-1β, IL-6, IL-8, and IL-18), TBI biomarkers [S100B, Neuron-Specific Enolase (NSE), and epinephrine].

PubMed files the paper under topics including Brain Injuries, Traumatic, Adrenergic beta-Antagonists, Biomarkers, Troponin T, Propranolol, Glasgow Coma Scale and Cytokines.

Author keywords: Beta-blocker, Inflammatory cytokines and Traumatic brain injury.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cerebrolysin in 771 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2024 (Scientific reports), a journal based in England.

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