DATA DICTIONARY FOR THE DATA SET CRASH-2 DATA FOR SUNGAI BULOH

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Shon Wilkerson
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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

1 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 1 of 7

2 DATA DEFINITION FILE FOR CRASH-2 DATASET: CRASH-2 data.csv (Excel comma separated value file) imum ientryid Unique number assigned by 5 Integer Range 1 to the database to each entry form on entry into the database 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 4 = paper CRF entered onto electronic CRF by Trial Coordinating Centre 5 = electronic CRF uploaded onto trandomised ioutcomeid Date and time of randomisation of the patient Unique number assigned by the database to each outcome form on entry into the database Date and time stamp entered automatically by computer upon randomisation at Clinical Trials Service Unit isex Sex of the patient Q.4 Patient sex 8 Date and time Crashnet (Trial) server Format DD/MM/YYYY HH:MM:SS 5 Integer Range 1 to Integer 1 = Male 2 = Female DATA DICTIONARY: CRASH-2 data.csv Page 2 of 7

3 iage ninjurytime Estimated age of the patient if date of birth not known Number of hours since injury Q7b NO approximate age Q.8 Estimated number of hours since injury iinjurytype Type of injury Q.9 Type of injury isbp Systolic blood pressure in mmhg Q.10 Systolic BP irr Respiratory rate per minute Q.11 Respiratory rate icc Central capillary refill time in seconds Q.12 Central capillary refill time ihr Heart rate per minute Q.13 Heart rate igcseye Glasgow Coma Score eye opening Q.14 Eye opening igcsmotor Glasgow Coma Score motor response Q.14 Motor response igcsverbal Glasgow Coma Score verbal igcs response Glasgow Coma Score total score Q14. Verbal response Q14. Glasgow Coma Score 2 Integer Range 1 to 99 2 Number Range 0.1 to 96 0 and 999 = missing data 1 Integer 1 = Blunt 2 = Penetrating 3 = Blunt and penetrating 3 Integer Range 4 to 250 NULL (blank), 0 and 999 = missing data 2 Integer Range 1 to 96 NULL (blank) and 0 = missing data 2 Integer Range 1 to 60 3 Integer Range 3 to Integer Range 1 to 4 1 Integer Range 1 to 6 1 Integer Range 1 to 5 2 Integer Range 3 to 15 DATA DICTIONARY: CRASH-2 data.csv Page 3 of 7

4 ddeath Date of death Q.3.1 Date of death icause Main cause of death Q.3.1 Cause of death scauseother istatus ddischarge Description of cause of death if entered as Other Status of patient at Outcome if alive Date of discharge, transfer to other hospital or day 28 from randomisation Q.3.1 Other - describe Q.3.2 Discharged/Still in this hospital now Q.3.2 Date of discharge/date 8 Date Format DD/MM/YYYY 1 Integer 1 = Bleeding, 2 = Head injury 3 = Myocardial infarction 4 = Stroke 5 = Pulmonary embolism 6 = Multi organ failure 7 = Other 60 String Free text 1 Integer 1 = Discharged, 2 = Still in hospital now 3 = Transferred to other hospital if patient alive at outcome 8 Date Format DD/MM/YYYY DATA DICTIONARY: CRASH-2 data.csv Page 4 of 7

5 icondition ndaysicu bheadinj bneuro Condition of patient at outcome if alive Number of days spent in Intensive Care Unit Significant head injury Yes Neurosurgical operation Yes Q3.3 IF ALIVE TICK ONE BOX THAT BEST DESCRIBES THE PATIENT S CONDITION Q.4 a) Days in Intensive Care Unit Q.4 b) Significant Head Injury Neurosurgical bchest Chest operation Yes Chest babdomen Abdomen operation Yes or Abdomen bpelvis Pelvis operation Yes Pelvis 1 Integer 1 = 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 if patient alive at outcome 3 Number Range 0 to 58 NULL (blank), 99 and 999 = missing data 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = DATA DICTIONARY: CRASH-2 data.csv Page 5 of 7

6 bpe bdvt Pulmonary embolism Yes or Deep vein thrombosis Yes Q5. Complications Pulmonary Embolism Deep Vein Thrombosis bstroke Stroke Yes Stroke bbleed bmi bgi bloading bmaint btransf Operation for bleeding Yes Myocardial infarction Yes or Gastrointestinal bleed Yes Complete loading dose of trial treatment given Yes or Complete maintenance dose of trial treatment given Yes Blood products transfusion Yes Operation for bleeding Myocardial Infarction Gastrointestinal bleeding Q.6 a) Complete loading dose given Q.6 b) Complete maintenance dose given Q.7 a) Blood products transfusion 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = 1 Boolean 0 = DATA DICTIONARY: CRASH-2 data.csv Page 6 of 7

7 ncell nplasma nplatelets ncryo bvii iboxid ipacknum Number of units of red cell products transfused Number of units of fresh frozen plasma transfused Number of units of platelets transfused Number of units of cryoprecipitate transfused Recombinant Factor VIIa given Yes Treatment box number. In combination with the pack number forms the unique 6 digit ID number of the patient (e.g ) Treatment pack number. In combination with the box number forms the unique 6 digit ID number of the patient (e.g ) Red cell products Fresh frozen plasma Platelets Cryoprecipitate Recombinant Factor VIIa Box Pack Type 2 Number Range 0 to 60 2 Number Range 0 to 60 2 Number Range 0 to 87 2 Number Range 0 to 61 Codes 1 Boolean 0 = 4 Integer Format 4-digit number starting 2,3,4,5,8, or 9 2 Integer Format 2-digit number starting 2,3,4,5,8 or 9 DATA DICTIONARY: CRASH-2 data.csv Page 7 of 7

Contents. Version 1.0: 01/02/2010 Protocol# ISRCTN Page 1 of 7

Contents. Version 1.0: 01/02/2010 Protocol# ISRCTN Page 1 of 7 Contents 1. INTRODUCTION... 2 2. STUDY SYNOPSIS... 2 3. STUDY OBJECTIVES... 2 3.1. Primary Objective... 2 3.2. Secondary Objectives... 2 3.3. Assessment of Objectives... 3 3.4. Change the Primary Objective