Effects of the bradykinin antagonist Bradycor (deltibant, CP-1027) in severe traumatic brain injury: results of a multi-center, randomized, placebo-controlled trial. American Brain Injury Consortium Study Group.

What Was Tested

The paper reports a study of Peptides, published as a randomized controlled trial.

A secondary objective was to evaluate the safety of Bradycor in patients with severe brain injury.

Why It Was Studied

A phase II prospective, randomized, double blind clinical trial of Bradycor, a bradykinin antagonist, was conducted at 31 centers within North America in severely brain injured patients.

Randomization was carried out according to a computer generated randomization list.

Who Took Part

By PubMed's age tags, the people studied were teenagers, adults, middle-aged adults and older adults, both men and women.

Patients were followed for the first 14 days of hospitalization with long-term outcome assessed at 3 and 6 months after injury.

How the Study Was Run

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

The participants were allocated by chance, so the Peptides group and the comparison group should start out alike.

As a double-blind Peptides study, the assignments were hidden from both participants and investigators until the end.

Some participants received a placebo instead of Peptides, giving a reference point.

What Was Measured

During the infusion and while the ICP monitor was in place, ICP measurements were recorded hourly along with blood pressure and heart rate.

Topics PubMed links to this paper include Bradykinin Receptor Antagonists, Brain Injuries, Glasgow Coma Scale, Intracranial Pressure, Neuroprotective Agents, Neuropsychological Tests and Peptides.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Peptides.

The publication is from 1999 (Journal of neurotrauma), a journal based in United States.

More context: all human trials.