Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticoststeriod in adults with head injury- outcomes at 6 months.
(Published in The Lancet journal in 2005, by the CRASH Trial collaborators)
Written by Rachel Williams (Research Nurse)
Edited by Lucia M Li
INTRODUCTION
CRASH was a large international study and this paper details its findings and subsequent recommendations. Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Every year millions will receive emergency treatment and 1.5 million will die as a result of the injury. This study wanted to establish if there was any benefit in using corticosteroids drugs in the emergency treatment of TBI. This is because these drugs were commonly used to treat TBI, and appeared to reduce mortality (the risk of dying). It is thought that these types of drugs can reduce the brain swelling that often occurs after severe brain injuries and, in doing so, help increase survival and recovery.
METHODS
Patients who had suffered a TBI were selected for the study. Because the study was specifically looking at whether corticosteroids would be helpful if used early on in the course of injury, the patient was only recruited if they had the injury <8 hours ago. Patients recruited into the trial were randomly assigned to two groups: patients in one group were given the corticosteroid drug and the other group was given a placebo medication. A total of 10,008 adults were took part in the CRASH trial, from many different countries (though not from either the US or Canada). The doctors giving the medicine did not know if they were giving the corticosteroid or a placebo. This is was important to ensure unbiased results. The researchers wanted to know two main things.
1) Did the patients receiving corticosteroid have a lower risk of dying within 2 weeks than those receiving placebo?
2) Did the patients receiving corticosteroid have a better recovery at 6 months than those receiving placebo?
RESULTS
The researchers found that the risk of dying and the risk of having a poor recovery were actually slightly higher in the group of patients receiving corticosteroids, compared with the group receiving placebo.
DISCUSSION
A real strength of this study was that a large number of patients participated in this study and information about recovery outcomes were collected in the vast majority (96%). This trial also gathered a great deal of information about recovery after TBI itself, which could be used determine the factors that are useful for predicting recovery of patients after TBI.
A limitation of this trial is that outcome information was not available for every single patient that was originally recruited. However, this trial was able to collect information for >96%. Another potential flaw with the study is that the other treatments which patients received were not known, so it is possible that those treatments influenced the results. The assumption is that, because patients were assigned to each group (corticosteroids or placebo) at random, these differences would not be significant between the groups. This trial was also not able to determine why corticosteroids appeared to make things worse.
Nevertheless, the results of this trial have been very influential. This trial has changed the way doctors look after patients who have had traumatic brain injuries. Prior to this study, corticosteroids were routinely used in the emergency setting to treat the brain injury. This study showed that corticosteroids provided no benefit. So, currently, unless a patient requires corticosteroids for treating other problems, s/he would not routinely receive corticosteroids for treating their brain injury in the emergency setting. These kind of trials are incredibly important for helping doctors make good treatment decisions for their patients.
The original article published in The Lancet, a general medical journal is online here - but it has not been made open access.
(Published in The Lancet journal in 2005, by the CRASH Trial collaborators)
Written by Rachel Williams (Research Nurse)
Edited by Lucia M Li
INTRODUCTION
CRASH was a large international study and this paper details its findings and subsequent recommendations. Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Every year millions will receive emergency treatment and 1.5 million will die as a result of the injury. This study wanted to establish if there was any benefit in using corticosteroids drugs in the emergency treatment of TBI. This is because these drugs were commonly used to treat TBI, and appeared to reduce mortality (the risk of dying). It is thought that these types of drugs can reduce the brain swelling that often occurs after severe brain injuries and, in doing so, help increase survival and recovery.
METHODS
Patients who had suffered a TBI were selected for the study. Because the study was specifically looking at whether corticosteroids would be helpful if used early on in the course of injury, the patient was only recruited if they had the injury <8 hours ago. Patients recruited into the trial were randomly assigned to two groups: patients in one group were given the corticosteroid drug and the other group was given a placebo medication. A total of 10,008 adults were took part in the CRASH trial, from many different countries (though not from either the US or Canada). The doctors giving the medicine did not know if they were giving the corticosteroid or a placebo. This is was important to ensure unbiased results. The researchers wanted to know two main things.
1) Did the patients receiving corticosteroid have a lower risk of dying within 2 weeks than those receiving placebo?
2) Did the patients receiving corticosteroid have a better recovery at 6 months than those receiving placebo?
RESULTS
The researchers found that the risk of dying and the risk of having a poor recovery were actually slightly higher in the group of patients receiving corticosteroids, compared with the group receiving placebo.
DISCUSSION
A real strength of this study was that a large number of patients participated in this study and information about recovery outcomes were collected in the vast majority (96%). This trial also gathered a great deal of information about recovery after TBI itself, which could be used determine the factors that are useful for predicting recovery of patients after TBI.
A limitation of this trial is that outcome information was not available for every single patient that was originally recruited. However, this trial was able to collect information for >96%. Another potential flaw with the study is that the other treatments which patients received were not known, so it is possible that those treatments influenced the results. The assumption is that, because patients were assigned to each group (corticosteroids or placebo) at random, these differences would not be significant between the groups. This trial was also not able to determine why corticosteroids appeared to make things worse.
Nevertheless, the results of this trial have been very influential. This trial has changed the way doctors look after patients who have had traumatic brain injuries. Prior to this study, corticosteroids were routinely used in the emergency setting to treat the brain injury. This study showed that corticosteroids provided no benefit. So, currently, unless a patient requires corticosteroids for treating other problems, s/he would not routinely receive corticosteroids for treating their brain injury in the emergency setting. These kind of trials are incredibly important for helping doctors make good treatment decisions for their patients.
The original article published in The Lancet, a general medical journal is online here - but it has not been made open access.