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. CRASH-2 is a randomised, controlled, double-blind trial undertaken in 274 hospitals in 40 countries. A total of 20211 adult trauma patients, with, or at risk of, significant bleeding (haemorrhage) were randomly assigned within 8 hours of injury to either tranexamic acid (TXA) or matching placebo. The primary outcome was death in hospital within four weeks of injury and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. This dataset is available at https://freebird.lshtm.ac.uk/index.php/data-sharing/downloads/crash2

CRASH-2 Collaborators

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. CRASH-2 is a randomised, controlled, double-blind trial undertaken in 274 hospitals in 40 countries. A total of 20211 adult trauma patients, with, or at risk of, significant bleeding (haemorrhage) were randomly assigned within 8 hours of injury to either tranexamic acid (TXA) or matching placebo. The primary outcome was death in hospital within four weeks of injury and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other

CRASH-2 Collaborators,

Name not available

CRASH-2 - Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage

LSHTM Data Compass

DATA DICTIONARY: CRASH-2 data.csv  Page 1 of 7 Protocol #ISRCTN23625128         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 DICTIONARY: CRASH-2 data.csv  Page 2 of 7 Protocol #ISRCTN23625128  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   DATA DICTIONARY: CRASH-2 data.csv  Page 3 of 7 Protocol #ISRCTN23625128 Variable Label Comments Max Length Type Codes 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     DATA DICTIONARY: CRASH-2 data.csv  Page 4 of 7 Protocol #ISRCTN23625128 Variable Label Comments Max Length Type Codes 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             DATA DICTIONARY: CRASH-2 data.csv  Page 5 of 7 Protocol #ISRCTN23625128 Variable Label Comments Max Length Type Codes 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   DATA DICTIONARY: CRASH-2 data.csv  Page 6 of 7 Protocol #ISRCTN23625128 Variable Label Comments Max Length Type Codes 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  DATA DICTIONARY: CRASH-2 data.csv  Page 7 of 7 Protocol #ISRCTN23625128 Variable Label Comments Max Length Type Codes 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  

CRASH-2 - Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage

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