Sucess for brain injury study

01 November 2012

The re-launch at Queen Elizabeth Hospital Birmingham of a clinical trial looking at treatment for serious head injuries has made the hospital one of Europe’s leading centres for this study.

The SyNAPSe study is investigating the use of a drug called progesterone, which is also known as P4 and has been shown in other studies to have a protective effect on damaged brain tissue.

Dr Mav Manji

Dr Mav Manji

In July the trial was re-launched at QEHB under the auspices of the new NIHR Surgical Reconstruction and Microbiology Research Centre (SRMRC).

An initial target was established to recruit one patient per month to the trial.

Increased collaboration between the hospital’s Emergency Department, Critical Care wards and the SRMRC’s research nursing team has already led to seven patients being recruited since July 2.

This puts QEHB on a par with Universitätsklinikum Gießen und Marburg GmbH in Germany among the highest recruiting centres in Western Europe since July, while only The Royal London Hospital has recruited more patients in England over the entire twoyear life of the study.

Consultant in critical care, Dr Mav Manji, the hospital’s principal investigator for the trial, said: “Our initial aim was for one patient per month but with the research nurse team under Aisling Clarkson working so well together with the Emergency Department and ITU, we have the highest rate of recruitment in Europe.

“This is a very exciting trial because it is a new drug and these patients with serious head injuries can end up with devastating disabilities.”

The trial involves patients receiving either progesterone or a placebo, so researchers can compare the results.

It is hoped that the drug will help to protect the patient’s neurons during the crucial hours shortly after an injury and then help with the healing process.

The trial is randomised and doubleblinded, which means the trial computer randomly chooses either the drug or the placebo for each patient and neither clinician nor patient is given that information.

The trial will be reviewed shortly by an independent group to check on progress.

Significant success for the drug could mean the trial ends early and progesterone could become a standard treatment for serious head injury; similarly, failure of the drug could cause the trial to be abandoned.

The independent group can also recommend the trial continues to gather more data.

The QEHB team will be waiting for interest to see the outcome of that interim report: “An independent group will be reviewing the data so far and releasing a report early next year. In the meantime, we carry on full steam ahead,” said Dr Manji.