CRASH - Corticosteroid Randomisation after Significant Head Injury

A LARGE SIMPLE PLACEBO CONTROLLED TRIAL, AMONG ADULTS WITH HEAD INJURY AND IMPAIRED CONSCIOUSNESS, OF THE EFFECTS OF A 48-HOUR INFUSION OF CORTICOSTEROIDS ON DEATH AND NEUROLOGICAL DISABILITY

DATA DICTIONARY FOR THE DATA SET CRASH DATA (CRASH data.csv)

EXCLUDED FROM THE CRASH DATA SET ARE THE VARIABLES:Country, hospital code and intervention. THESE VARIABLES MAY BE REQUESTED FROM THE CTU. A SUMMARY PROTOCOL DETAILING THE USE THAT WILL BE MADE OF THIS DATA MUST BE PROVIDED WITH THE REQUEST.

DATA DEFINITION FILE FOR CRASH DATASET:  CRASH data.csv   (Excel comma separated value file)
Variable Label Comments Maximum Type Codes
Length
BASELINE DATA
Patient ID Six digit unique identifier for Derived from the 7 String
each patient treatment box-pack
number
SEX Gender of the patient 1 Number 0 = Male
1 = Female
AGE Estimated age in years if 2 Number -1 = DOB known and entered
DOB not known
DRAND Date of randomisation DD/MM/YYYY 10 Date
TRAND Time of randomisation HH:MM:SS 8 Time
MINS_SINCE_INJURY Number of minutes since 4 Number
injury
GCS_EYE Glasgow Coma Scale: Eye 1 Number 4 = Spontaneous
opening 3 = To sound
2 = To pain
1 = None
GCS_MOTOR Glasgow Coma Scale: Motor 1 Number 6 = Obeys commands
response 5 = Localising
4 = Normal flexion
3 = Abnormal flexion
2 = Extending
1 = None
GCS_VERBAL Glasgow Coma Scale: Verbal 1 Number 5 = Orientated
response 4 = Confused speech
3 = Words
2 = Sounds
1 = None
Variable Label Comments Maximum Type Codes
Length
IS_GCS_CURRENT Indicates whether GCS is 1 Number 1 = Current
current or most recent 2 = Most recent
PUPIL_REACT_LEFT Pupil reactiveness left eye 1 Number 1 = Yes
2 = No
3 = Unable to assess
PUPIL_REACT_RIGHT Pupil reactiveness right eye 1 Number 1 = Yes
2 = No
3 = Unable to assess
EARLY OUTCOME DATA – within two weeks from randomisation – FORM COMPLETED AT ADMITTING HOSPITAL [EO= early outcome form]
EO_Cause Cause of injury 1 Number 1 = Road Traffic Accident
2 = Fall >2 metres
3 = Other
EO_Cause specified Description of other cause 68 String Free text
of injury
EO_Outcome Dead or alive within two 1 Number 1 = Death in hospital
weeks after injury 2 = Transferred to other acute care
hospital
3 = Discharged to rehabilitation centre
or nursing home
4 = Discharged home
5 = Still in this hospital now
EO_Date of outcome Date of outcome 10 Date
Variable Label Comments Maximum Type Codes
Length
EO_Symptoms Condition of patient at early 1 Number 1 = No symptoms
outcome 2 = Minor symptoms
3 = Some restriction in lifestyle but
independent
4 = Dependent, but not requiring
constant attention
5 = Fully dependent, requiring attention
day and night
6 = Dead
9 = Known to be alive at 6M but
symptoms not known at day 14
EO_Days ICU Number of days spent in 2 Number
Intensive Care Unit
EO_Seizure Seizure Yes or No 1 Number 1 = Yes
2 = No
EO_Haematemesis or Haematemesis or melaena 1 Number 1 = Yes
melaena requiring transfusion Yes or 2 = No
No
EO_Wound infection Wound infection with pus 1 Number 1 = Yes
Yes or No 2 = No
EO_Pneumonia Pneumonia treated with 1 Number 1 = Yes
TWAB antibiotics Yes or No 2 = No
EO_Other TWAB Other treated with 1 Number 1 = Yes
antibiotics Yes or No 2 = No
EO_Neurosurgical Neurosurgical operation Yes 1 Number 1 = Yes
or No 2 = No
EO_Major EC injury Major extracranial injury 1 Number 1 = Yes
Yes or No 2 = No
Variable Label Comments Maximum Type Codes
Length
EO_Head CT scan Head CT scan done Yes or 1 Number 1 = Yes
No 2 = No
EO_Date of CT Date and time of CT scan DD/MM/YYYY 10 Date and
HH:MM:SS time
EO_Normal scan Normal scan Yes or No 1 Number 1 = Yes
2 = No
EO_1 or more PH 1 or more petechial 1 Number 1 = Yes
haemorrhages within the 2 = No
brain Yes or No
EO_Obliteration Obliteration of the 3rd 1 Number 1 = Yes
3rdVorBC ventricle or basal cisterns 2 = No
Yes or No
EO_Subarachnoid Subarachnoid bleed Yes or 1 Number 1 = Yes
bleed No 2 = No
EO_Midline shift Midline shift >5mm Yes or 1 Number 1 = Yes
>5mm No 2 = No
EO_Non-evac haem Intracranial haematoma 1 Number 1 = Yes
non-evacuated Yes or No 2 = No
EO_Evac haem Intracranial haematoma 1 Number 1 = Yes
evacuated Yes or No 2 = No
EO_Loading Loading dose of trial 1 Number 1 = Yes
treatment given Yes or No 2 = No
EO_Maintenance Number of hours of 2 Number
maintenance dose of trial
treatment given
EARLY OUTCOME DATA – within two weeks from randomisation – FORM COMPLETED AT HOSPITAL PATIENT WAS TRANSFERRED TO [TH=transfer hospital early outcome form]
Variable Label Comments Maximum Type Codes
Length
TH_Cause Cause of injury 1 Number 1 = Road Traffic Accident
2 = Fall >2 metres
3 = Other
TH_Cause specified Description of other cause 48 String Free text
of injury
TH_Outcome Dead or alive at transfer 1 Number 1 = Death in hospital
hospital within two weeks 2 = Transferred to other acute care
after injury hospital
3 = Discharged to rehabilitation centre
or nursing home
4 = Discharged home
5 = Still in this hospital now
TH_Date of outcome Date of outcome DD/MM/YYYY 10 Date
TH_Symptoms Condition of patient at early 1 Number 1 = No symptoms
outcome 2 = Minor symptoms
3 = Some restriction in lifestyle but
independent
4 = Dependent, but not requiring
constant attention
5 = Fully dependent, requiring attention
day and night
6 = Dead
9 = Known to be alive at 6M but
symptoms not known at day 14
TH_Days ICU Number of days spent in 2 Number
Intensive Care Unit
Variable Label Comments Maximum Type Codes
Length
TH_Seizure Seizure Yes or No 1 1 = Yes
2 = No
TH_Haem or mel Haematemesis or melaena 1 Number 1 = Yes
requiring transfusion Yes or 2 = No
No
TH_Wound infection Wound infection with pus 1 Number 1 = Yes
Yes or No 2 = No
TH_Pneumonia Pneumonia treated with 1 Number 1 = Yes
TWAB antibiotics 2 = No
TH_Other TWAB Other treated with 1 Number 1 = Yes
antibiotics Yes or No 2 = No
TH_Neurosurgical Neurosurgical operation Yes 1 Number 1 = Yes
or No 2 = No
TH_Major EC injury Major extracranial injury 1 Number 1 = Yes
Yes or No 2 = No
TH_Head CT scan Head CT scan done Yes or 1 Number 1 = Yes
No 2 = No
TH_Date of CT Date of CT scan 10 Date
TH_Normal scan Normal scan Yes or No 1 Number 1 = Yes
2 = No
TH_1 or more PH One or more petechial 1 Number 1 = Yes
haemorrhages within the 2 = No
brain Yes or No
TH_Obliteration Obliteration of the 3rd 1 Number 1 = Yes
3rdVorBC ventricle or basal cisterns 2 = No
TH_Subarachnoid Subarachnoid bleed Yes or 1 Number 1 = Yes
bleed No 2 = No
Variable Label Comments Maximum Type Codes
Length
TH_Midline shift Midline shift >5mm Yes or 1 Number 1 = Yes
>5mm No 2 = No
TH_Non-evac haem Intracranial haematoma 1 Number 1 = Yes
non-evacuated Yes or No 2 = No
TH_Evac haem Intracranial haematoma 1 Number 1 = Yes
evacuated Yes or No 2 = No
TH_Loading Loading dose of trial 1 Number 1 = Yes
treatment given Yes or No 2 = No
TH_Maintenance Number of hours 2 Number
maintenance dose of trial
treatment given
SIX MONTH OUTCOME (5 level questionnaire)
6M5_Who Who completed the 1 Number 1 = Patient alone
questionnaire 2 = Relative, friend or carer alone
3 = Patient and relative, friend or carer
together
6M5_Living Where the patient lives 1 Number 1 = In own home
2 = In hospital
3 = In residential care
6M5_Home Help required in the home 1 Number 1 = No
2 = Yes. I need some help in the home
but not every day
3 = Yes. I need help in the home every
day
4 = I need help in the home, but not
because of the injury
Variable Label Comments Maximum Type Codes
Length
6M5_Shopping Help needed to shop 1 Number 1 = No
2 = Yes. I need some help, but can go to
the shops on my own
3 = Yes. I need help to shop even
locally, or I cannot shop at all
4 = I need help to shop, but not because
of the injury
6M5_Travelling Help needed to travel 1 Number 1 = No
2 = Yes. I need some help but can travel
on my own (e.g. by arranging a taxi)
3 = Yes. I need help to travel even
locally, or I cannot travel at all
4 = I need help to travel, but not
because of the injury
6M5_Working Any change in ability to 1 Number 1 = No
work, ( or to study if a 2 = Yes. I still work, but at a reduced
student; or to look after level (e.g. a change from full-time to
family) part-time, or a change in level of
responsibility)
3 = Yes. I am unable to work at present
4 = My ability to work is restricted, but
not because of the injury, or I have
retired
6M5_Leisure Change in ability to take 1 Number 1 = No
part in social and leisure 2 = Yes. I take part a bit less, but at
activities outside home least half as often
3 = Yes. I take part much less, or do not
take part at all
4 = My ability to take part is restricted
for some other reason, not because of
the injury
Variable Label Comments Maximum Type Codes
Length
6M5_Relationships Problems in getting on with 1 Number 1 = No
friends and relatives 2 = Yes. There are occasional problems
(less than once a week)
3 = Yes. There are frequent or constant
problems
4 = There are problems for some other
reason, not because of the injury
GOS5 Overall assessment 3 String GR = Good Recovery
MD = Moderate Disability
SD = Severe Disability
SD* = Severe Disability not related to
the injury
VS = Vegetative State
D = Death
SIX MONTH OUTCOME (8 level questionnaire)
6M8_Who Who completed the 1 Number 1 = Patient alone
questionnaire 2 = Relative, friend or carer alone
3 = Patient and relative, friend or carer
together
6M8_Living Where the patient lives 1 Number 1 = In own home
2 = In hospital
3 = In residential care
6M8_Home Pre- Able to look after oneself at 1 Number 1 = Yes
injury home before the injury 2 = No
Variable Label Comments Maximum Type Codes
Length
6M8_Home Help required in the home 1 Number 1 = I do not need help or supervision in
the home
2 = I need some help in the home, but
not every day
3 = I need help in the home every day,
but I could look after myself for at least
8 hours if necessary
4 = I could not look after myself for 8
hours during the day
5 = I need help in the home, but not
because of the injury
6M8_Shopping Pre- Help needed to shop before 1 Number 1 = Yes
injury the injury 2 = No
6M8_Shopping Help needed to shop 1 Number 1 = I do need help to shop
2 = I need some help, but I can go to
local shops on my own
3 = I need help to shop even locally, or I
cannot shop at all
4 = I need help to shop, but not because
of the injury
6M8_Travelling Pre- Help needed to travel 1 Number 1 = Yes
injury before the injury 2 = No
6M8_Travelling Help needed to travel 1 Number 1 = I do not need help to travel
2 = I need some help, but can travel
locally on my own (e.g. by arranging a
taxi)
3 = I need help to travel even locally, or I
cannot travel at all
4 = I need help to travel but not because
of the injury
Variable Label Comments Maximum Type Codes
Length
6M8_Working Pre- Employment before the 1 Number 1 = Working
injury injury 2 = Looking after the family
3 = Retired
4 = Looking for work
5 = Studying as a student
6 = None of these (e.g. unfit for work)
6M8_Working Change in ability to work 1 Number 1 = I can still do the same work
2 = I can still work, but at a reduced
level (e.g. change from full-time to part-
time, or change in level of responsibility
3 = I am unable to work, or only able to
work in sheltered workshop
4 = My ability to work has changed, but
not because of the injury
6M8_Leisure Pre- Able to take part in regular Social and leisure 1 Number 1 = Yes
injury social and leisure activities activities include: going 2 = No
out to a pub or club,
outside the home before
visiting friends, going to
the injury
the cinema or bingo,
going out for a walk,
attending a football
match, taking part in sport
6M8_Leisure Able to take part in regular 1 Number 1 = I take part about as often as before
social and leisure activities (the activities may be different from
outside the home before)
2 = I take part less often, but at least
half as often
3 = I take part much less, less than half
as often
4 = I do not take part at all
5 = My ability to take part has changed
for some other
Variable Label Comments Maximum Type Codes
Length
6M8_Relationships Problems getting on with 1 Number 1 = Yes
Pre-injury friends or relatives before 2 = No
the injury
6M8_Relationships Problems getting on with 1 Number 1 = Things are still much the same
friends or relatives 2 = There are occasional problems (less
than once a week)
3 = There are frequent problems (once a
week or more)
4 = There are constant problems
(problems every day)
5 = There are problems for some other
reason, not because of the injury
6M8_Other Any problems resulting Problems sometimes 1 Number 1 = I have no current problems
problems from the injury which reported after head 2 = I have some problems, but these do
injury: headaches,
interfere with daily life not interfere with my daily life
dizziness, tiredness,
3 = I have some problems, but these
sensitivity to noise or
light, slowness, memory have affected my daily life
failures, and 4 = I have some problems for other
concentration problems reasons, not because of the head injury
6M8_Similar Similar problems before the 1 Number 1 = I had no problems before, I had
problems Pre-injury injury minor problems before
2 = I had similar problems before
GOS8 3 String GR - = lower Good Recovery
GR + = upper Good Recovery
MD - = lower Moderate Disability
MD + = upper Moderate Disability
SD - = lower Severe Disability
SD + = upper Severe Disability
SD* = Severe Disability not related to
the injury
D = Death
Variable Label Comments Maximum Type Codes
Length
EO_Tracking code Lost to follow up 1 Number 11 = Lost to follow up
6M_Tracking code Status of patient lost to 1 Number 35 = Lost to follow-up
follow up and known to be 36 = Known to be dead
dead or alive 6 months after 38 = Known to be alive
injury from source other
than 6 month outcome
form