A large randomised placebo controlled trial among trauma patients with or at risk of significant haemorrhage, of the effects of antifibrinolytic treatment on death and transfusion requirement
DATA DICTIONARY FOR THE DATA SET CRASH-2 DATA FOR SUNGAI BULOH EXCLUDED FROM THE CRASH-2 DATA IS THE VARIABLE: TREATMENT CODE
| DATA DEFINITION FILE FOR CRASH-2 DATASET: CRASH-2 data.csv (Excel comma separated value file) | |||||
| Variable | Label | Comments | Maximum Length | Type | Codes |
| ientryid | Unique number assigned by the database to each entry form on entry into the database | 5 | Integer | Range 1 to 20270 | |
| isource | Method by which the entry form was sent to the trial coordinating centre | 1 | Integer | 1 = Telephone randomisation via Clinical Trials Service Unit (CTSU) 2 = Telephone randomisation via Clinical Trials Service Unit entered manually by CTSU 3 = electronic CRF sent via email 4 = paper CRF entered onto electronic CRF by Trial Coordinating Centre 5 = electronic CRF uploaded onto Crashnet (Trial) server | |
| trandomised | Date and time of randomisation of the patient | Date and time stamp entered automatically by computer upon randomisation at Clinical Trials Service Unit | 8 | Date and time | Format DD/MM/YYYY HH:MM:SS |
| ioutcomeid | Unique number assigned by the database to each outcome form on entry into the database | 5 | Integer | Range 1 to 20199 | |
| isex | Sex of the patient | Patient Entry Q.4 Patient sex | 1 | Integer | 1 = Male 2 = Female NULL (blank) = missing data |
| iage | Estimated age of the patient if date of birth not known | Patient Entry Q7b NO – approximate age | 2 | Integer | Range 1 to 99 NULL (blank) = missing data |
| ninjurytime | Number of hours since injury | Patient Entry Q.8 Estimated number of hours since injury | 2 | Number | Range 0.1 to 96 0 and 999 = missing data |
| iinjurytype | Type of injury | Patient Entry Q.9 Type of injury | 1 | Integer | 1 = Blunt 2 = Penetrating 3 = Blunt and penetrating |
| isbp | Systolic blood pressure in mmHg | Patient Entry Q.10 Systolic BP | 3 | Integer | Range 4 to 250 NULL (blank), 0 and 999 = missing data |
| irr | Respiratory rate per minute | Patient Entry Q.11 Respiratory rate | 2 | Integer | Range 1 to 96 NULL (blank) and 0 = missing data |
| icc | Central capillary refill time in seconds | Patient Entry Q.12 Central capillary refill time | 2 | Integer | Range 1 to 60 NULL (blank) = missing data |
| ihr | Heart rate per minute | Patient Entry Q.13 Heart rate | 3 | Integer | Range 3 to 220 NULL (blank) = missing data |
| igcseye | Glasgow Coma Score eye opening | Patient Entry Q.14 Eye opening | 1 | Integer | Range 1 to 4 NULL (blank) = missing data |
| igcsmotor | Glasgow Coma Score motor response | Patient Entry Q.14 Motor response | 1 | Integer | Range 1 to 6 NULL (blank) = missing data |
| igcsverbal | Glasgow Coma Score verbal response | Patient Entry Q14. Verbal response | 1 | Integer | Range 1 to 5 NULL (blank) = missing data |
| igcs | Glasgow Coma Score total score | Patient Entry Q14. Glasgow Coma Score | 2 | Integer | Range 3 to 15 NULL (blank) = missing data |
| ddeath | Date of death | Outcome Form Q.3.1 Date of death | 8 | Date | Format DD/MM/YYYY |
| icause | Main cause of death | Outcome Form Q.3.1 Cause of death | 1 | Integer | 1 = Bleeding, 2 = Head injury 3 = Myocardial infarction 4 = Stroke 5 = Pulmonary embolism 6 = Multi organ failure 7 = Other |
| scauseother | Description of cause of death if entered as “Other” | Outcome Form Q.3.1 Other - describe | 60 | String | Free text |
| istatus | Status of patient at Outcome if alive | Outcome Form Q.3.2 Discharged/Still in this hospital now | 1 | Integer | 1 = Discharged, 2 = Still in hospital now 3 = Transferred to other hospital NULL (blank) = missing data if patient alive at outcome |
| ddischarge | Date of discharge, transfer to other hospital or day 28 from randomisation | Outcome Form Q.3.2 Date of discharge/Date | 8 | Date | Format DD/MM/YYYY |
| icondition | Condition of patient at outcome if alive | Outcome Form Q3.3 IF ALIVE TICK ONE BOX THAT BEST DESCRIBES THE PATIENT’S CONDITION | 1 | Integer | 1 = No symptoms 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 NULL (blank) = missing data if patient alive at outcome |
| ndaysicu | Number of days spent in Intensive Care Unit | Outcome Form Q.4 a) Days in Intensive Care Unit | 3 | Number | Range 0 to 58 NULL (blank), 99 and 999 = missing data |
| bheadinj | Significant head injury Yes or No | Outcome Form Q.4 b) Significant Head Injury | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bneuro | Neurosurgical operation Yes or No | Outcome Form Q.4 c) Operation site Neurosurgical | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bchest | Chest operation Yes or No | Outcome Form Q.4 c) Operation site Chest | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| babdomen | Abdomen operation Yes or No | Outcome Form Q.4 c) Operation site Abdomen | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bpelvis | Pelvis operation Yes or No | Outcome Form Q.4 c) Operation site Pelvis | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bpe | Pulmonary embolism Yes or No | Outcome Form Q5. Complications Pulmonary Embolism | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bdvt | Deep vein thrombosis Yes or No | Outcome Form Q.5 Complications Deep Vein Thrombosis | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bstroke | Stroke Yes or No | Outcome Form Q.5 Complications Stroke | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bbleed | Operation for bleeding Yes or No | Outcome Form Q.5 Complications Operation for bleeding | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bmi | Myocardial infarction Yes or No | Outcome Form Q.5 Complications Myocardial Infarction | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bgi | Gastrointestinal bleed Yes or No | Outcome Form Q.5 Complications Gastrointestinal bleeding | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bloading | Complete loading dose of trial treatment given Yes or No | Outcome Form Q.6 a) Complete loading dose given | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| bmaint | Complete maintenance dose of trial treatment given Yes or No | Outcome Form Q.6 b) Complete maintenance dose given | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| btransf | Blood products transfusion Yes or No | Outcome Form Q.7 a) Blood products transfusion | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| ncell | Number of units of red cell products transfused | Outcome Form Q.7 b) Units transfused in 28 days Red cell products | 2 | Number | Range 0 to 60 |
| nplasma | Number of units of fresh frozen plasma transfused | Outcome Form Q.7 b) Units transfused in 28 days Fresh frozen plasma | 2 | Number | Range 0 to 60 |
| nplatelets | Number of units of platelets transfused | Outcome Form Q.7 b) Units transfused in 28 days Platelets | 2 | Number | Range 0 to 87 |
| ncryo | Number of units of cryoprecipitate transfused | Outcome Form Q.7 b) Units transfused in 28 days Cryoprecipitate | 2 | Number | Range 0 to 61 |
| bvii | Recombinant Factor VIIa given Yes or No | Outcome Form Q.7 b) Units transfused in 28 days Recombinant Factor VIIa | 1 | Boolean | 0 = No 1 = Yes NULL (blank) = missing data |
| iboxid | Treatment box number. In combination with the pack number forms the unique 6 digit ID number of the patient (e.g. 800081) | Patient Entry Box | 4 | Integer | Format 4-digit number starting 2,3,4,5,8, or 9 |
| ipacknum | Treatment pack number. In combination with the box number forms the unique 6 digit ID number of the patient (e.g. 800081) | Patient Entry Pack | 2 | Integer | Format 2-digit number starting 2,3,4,5,8 or 9 |