Overview
The BRAIN Trial was a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury. The results were published in the BMC in 2009. This trial did not reach the planned sample size of 400 patients and consequently, the study power to detect an increase in the risk of serious adverse events was reduced. This trial provides no reliable evidence of benefit or harm and a larger trial would be needed to establish safety and effectiveness.
Trial in numbers
228
Participants recruited
8
Recruiting countries
15
Hospitals
What is cerebral oedema?
Cerebral oedema, or brain swelling, is associated with significant rates of illness and death after traumatic brain injury (TBI). It develops soon after injury, reaching a maximum between three and five days post injury. An increase in the permeability of the blood-brain barrier (BBB) is believed to be responsible for oedema formation.
Bradykinin (BK) is a substance that plays a role in inflammation in the kinin-kallikrein system. After an injury, BK is produced immediately and can make the BBB more permeable, which can lead to swelling in the brain. The increase in permeability can also allow small solutes to pass through and increase blood pressure in small blood vessels.
This trial evaluated the safety and effectiveness of the drug bradykinin B2 receptor antagonist (BB2) Anatibant in the treatment of patients with traumatic brain injury.
BB2 block the activity of the kinin-kallikrein system, preventing the release of BK, and may reduce neuronal damage after TBI.
During the course of the trial, funding was withdrawn by the funder, Xytis.
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