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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02187120
Registration number
NCT02187120
Ethics application status
Date submitted
8/07/2014
Date registered
10/07/2014
Date last updated
27/01/2023
Titles & IDs
Public title
Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study)
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Scientific title
A Multi-centre Randomised, Double-blinded, Placebo-controlled Trial of Pre-hospital Treatment With Tranexamic Acid for Severely Injured Patients at Risk of Acute Traumatic Coagulopathy.
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Secondary ID [1]
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U1111-1160-6738
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Secondary ID [2]
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APP1044894
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Universal Trial Number (UTN)
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Trial acronym
PATCH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Wounds and Injuries
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Acute Coagulopathy
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tranexamic Acid
Experimental: Tranexamic Acid - As soon as possible after injury, emergency medical services clinicians will administer 1g Tranexamic Acid (10ml ampoule containing 100mg/ml Tranexamic Acid in water for injection) delivered intravenously using a slow push of the syringe.
As soon as possible after the patient arrives at hospital, clinicians will administer 1g Tranexamic acid (10ml ampoule containing 100mg/ml Tranexamic Acid in water for injection) added to up to one litre 0.9%w/v Sodium Chloride and the entire volume infused intravenously over 8 hours.
Placebo comparator: Placebo - As soon as possible after injury, emergency medical services clinicians will administer a 10ml ampoule containing 0.9%w/v Sodium Chloride via intravenous injection using a slow push of the syringe (ampoules containing Sodium Chloride appear identical to the ampoules containing Tranexamic Acid).
As soon as possible after the patient arrives at hospital, clinicians will administer a second 10 ml ampoule containing 0.9%w/v Sodium Chloride added to up to one litre 0.9%w/v Sodium Chloride and the entire volume infused intravenously over 8 hours.
Treatment: Drugs: Tranexamic Acid
Tranexamic acid is a synthetic lysine derivative that inhibits fibrinolysis by blocking the lysine binding sites on plasminogen therefore inhibiting the conversion of plasminogen to plasmin. Intravenous injection of 1g Tranexamic Acid will be administered in the pre-hospital setting followed by 1g Tranexamic Acid infused intravenously over 8 hours initiated in the hospital emergency department.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The proportion of patients with a favourable outcome (moderate disability or good recovery, GOSE scores 5-8) compared to those who have died (GOSE 1), or have severe disability (GOSE 2-4).
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Assessment method [1]
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Units of blood products used (red blood cells, plasma, platelets, prothrombin complex concentrate, fibrinogen, Factor VIIa, cryoprecipitate)
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Assessment method [1]
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Timepoint [1]
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24 hours
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Secondary outcome [2]
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Coagulation assessed using the international normalised ratio (INR)
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Assessment method [2]
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Timepoint [2]
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Immediately upon patient arrival to hospital
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Secondary outcome [3]
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Coagulation assessed using the international normalised ratio (INR)
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Assessment method [3]
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Timepoint [3]
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At the end of 8 hour infusion of study drug
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Secondary outcome [4]
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Coagulation assessed using the international normalised ratio (INR)
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Assessment method [4]
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Timepoint [4]
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24 hours after pre-hospital dose of study drug
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Secondary outcome [5]
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Coagulation assessed by activated partial thromboplastin time (APTT)
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Assessment method [5]
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Timepoint [5]
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Immediately upon patient arrival to hospital
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Secondary outcome [6]
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Coagulation assessed by activated partial thromboplastin time (APTT)
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Assessment method [6]
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Timepoint [6]
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At the end of 8 hour infusion of study drug
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Secondary outcome [7]
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Coagulation assessed by activated partial thromboplastin time (APTT)
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Assessment method [7]
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Timepoint [7]
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24 hours after pre-hospital dose of study drug
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Secondary outcome [8]
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Platelet count
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Assessment method [8]
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Timepoint [8]
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Immediately upon patient arrival to hospital
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Secondary outcome [9]
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Platelet count
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Assessment method [9]
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Timepoint [9]
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At the end of 8 hour infusion of study drug
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Secondary outcome [10]
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Platelet count
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Assessment method [10]
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Timepoint [10]
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24 hours after pre-hospital dose of study drug
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Secondary outcome [11]
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Vascular occlusive events (myocardial infarction, stroke, deep venous thrombosis (DVT), pulmonary embolus (PE))
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Assessment method [11]
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Timepoint [11]
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Hospital discharge (or up to 28 days in hospital)
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Secondary outcome [12]
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Ventilator-free days
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Assessment method [12]
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0
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Timepoint [12]
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28 days
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Secondary outcome [13]
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Mortality
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Assessment method [13]
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0
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Timepoint [13]
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24 hours
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Secondary outcome [14]
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Mortality
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Assessment method [14]
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Timepoint [14]
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28 days
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Secondary outcome [15]
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Mortality
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Assessment method [15]
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Timepoint [15]
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6 months
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Secondary outcome [16]
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Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
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Assessment method [16]
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Timepoint [16]
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24 hours
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Secondary outcome [17]
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Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
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Assessment method [17]
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Timepoint [17]
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28 days
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Secondary outcome [18]
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Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
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Assessment method [18]
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Timepoint [18]
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6 months
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Secondary outcome [19]
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Cumulative incidence of sepsis
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Assessment method [19]
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0
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Timepoint [19]
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Hospital discharge (or up to 28 days in hospital)
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Secondary outcome [20]
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Quality of life measured using WHODAS 2.0
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Assessment method [20]
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0
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Timepoint [20]
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6 months
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Secondary outcome [21]
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Quality of life measured using the EuroQOL 5 dimensions questionnaire (EQ-5D)
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Assessment method [21]
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0
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Timepoint [21]
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6 months
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Secondary outcome [22]
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Number of participants with serious adverse events
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Assessment method [22]
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Timepoint [22]
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hospital discharge (or up to 28 days in hospital)
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Secondary outcome [23]
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Coagulation assessed by fibrinogen
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Assessment method [23]
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0
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Timepoint [23]
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Immediately upon patient arrival to hospital
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Secondary outcome [24]
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Coagulation assessed by fibrinogen
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Assessment method [24]
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0
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Timepoint [24]
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At the end of 8 hour infusion of study drug
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Secondary outcome [25]
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Coagulation assessed by fibrinogen
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Assessment method [25]
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Timepoint [25]
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24 hours after pre-hospital dose of study drug
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Eligibility
Key inclusion criteria
* Adult patients (estimated age 18 years or older)
* Injured through any mechanism
* Coagulopathy of severe trauma (COAST) score of 3 points or greater
* First dose of study drug can be administered within three hours of injury
* Patients to be transported to a participating trauma centre
COAST score
* Entrapment (ie in vehicle) [Yes = 1, No = 0]
* Systolic blood pressure [<90 mmHg = 2, <100 mmHg = 1, =100 mmHg = 0]
* Temperature [<32? =2, <35? = 1, =35? = 0]
* Major chest injury likely to require intervention (e.g. decompression, chest tube) [Yes = 1, No = 0]
* Likely intra-abdominal or pelvic injury [Yes = 1, No = 0]
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Suspected pregnancy
* Nursing home residents
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/09/2022
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Sample size
Target
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Accrual to date
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Final
1310
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Lismore Base Hospital - Lismore
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Recruitment hospital [2]
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NNSW Medical Retrieval Service - Lismore
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Recruitment hospital [3]
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John Hunter Hospital - Newcastle
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Recruitment hospital [4]
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CareFlight - Northmead
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Recruitment hospital [5]
0
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Orange Base Hospital - Orange
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Recruitment hospital [6]
0
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Ambulance Service of New South Wales - Rozelle
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Recruitment hospital [7]
0
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [8]
0
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Liverpool Hospital - Sydney
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Recruitment hospital [9]
0
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Wagga Wagga Base Hospital - Wagga Wagga
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Recruitment hospital [10]
0
0
Westmead Hospital - Westmead
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Recruitment hospital [11]
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St John Ambulance - Darwin
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Recruitment hospital [12]
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Royal Darwin Hospital - Darwin
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Recruitment hospital [13]
0
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [14]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [15]
0
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Gold Coast Hospital - Gold Coast
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Recruitment hospital [16]
0
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Queensland Ambulance Service - Kedron
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Recruitment hospital [17]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [18]
0
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [19]
0
0
South Australia Ambulance Service - Eastwood
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Recruitment hospital [20]
0
0
Ambulance Tasmania - Hobart
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Recruitment hospital [21]
0
0
Royal Hobart Hospital - Hobart
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Recruitment hospital [22]
0
0
Ambulance Victoria - Melbourne
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Recruitment hospital [23]
0
0
The Alfred Hospital - Melbourne
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Recruitment hospital [24]
0
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [25]
0
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St John Ambulance Western Australia - Geraldton
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Recruitment hospital [26]
0
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2480 - Lismore
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Recruitment postcode(s) [2]
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2305 - Newcastle
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Recruitment postcode(s) [3]
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2152 - Northmead
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Recruitment postcode(s) [4]
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2800 - Orange
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Recruitment postcode(s) [5]
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2039 - Rozelle
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Recruitment postcode(s) [6]
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2065 - St Leonards
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Recruitment postcode(s) [7]
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2170 - Sydney
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Recruitment postcode(s) [8]
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2650 - Wagga Wagga
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Recruitment postcode(s) [9]
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2145 - Westmead
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Recruitment postcode(s) [10]
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0810 - Darwin
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Recruitment postcode(s) [11]
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0811 - Darwin
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Recruitment postcode(s) [12]
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4006 - Brisbane
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Recruitment postcode(s) [13]
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4102 - Brisbane
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Recruitment postcode(s) [14]
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4215 - Gold Coast
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Recruitment postcode(s) [15]
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4031 - Kedron
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Recruitment postcode(s) [16]
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5000 - Adelaide
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Recruitment postcode(s) [17]
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5042 - Bedford Park
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Recruitment postcode(s) [18]
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5063 - Eastwood
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Recruitment postcode(s) [19]
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7000 - Hobart
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Recruitment postcode(s) [20]
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2000 - Melbourne
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Recruitment postcode(s) [21]
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3004 - Melbourne
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Recruitment postcode(s) [22]
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3050 - Melbourne
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Recruitment postcode(s) [23]
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6530 - Geraldton
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Recruitment postcode(s) [24]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Albany
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Country [2]
0
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New Zealand
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State/province [2]
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Auckland
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Country [3]
0
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New Zealand
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State/province [3]
0
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Hamilton West
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Country [4]
0
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New Zealand
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State/province [4]
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Hastings
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Country [5]
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New Zealand
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State/province [5]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Health Research Council, New Zealand
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this research is to determine whether giving severely injured adults a drug called tranexamic acid (TXA) as soon as possible after injury will improve their chances of survival and their level of recovery at six months. After severe injury, a person may have uncontrolled bleeding that places them at high risk of bleeding to death. Coagulation (the formation of blood clots) is an important process in the body that helps to control blood loss. Up to a quarter of people that are severely injured have a condition called acute traumatic coagulopathy. This condition affects coagulation and results in the break down of blood clots (fibrinolysis) that can lead to increased blood loss and an increased risk of dying. TXA is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic coagulopathy by preventing blood clots from breaking down and helping to control bleeding. In Australia, TXA is approved for use by the Therapeutic Goods Administration (TGA) to reduce blood loss or the need for blood transfusion in patients undergoing surgery (i.e. cardiac surgery, knee or hip arthroplasty). Recent evidence from a large clinical trial (CRASH-2) showed early treatment with TXA reduced the risk of death in severely injured patients, however the majority of patients involved in the study were injured in countries where prehospital care is limited and rapid access to lifesaving treatments is limited compared to that available in countries like Australia and New Zealand. It is unclear whether TXA will reduce the risk of death to the same degree when it is given alongside other lifesaving treatments that are available to patients soon after injury in these countries. The hypothesis is that TXA given early to injured patients who are at risk of acute traumatic coagulopathy and who are treated in countries with systems providing advanced trauma care reduces mortality and improves recovery at 6-months after injury.
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Trial website
https://clinicaltrials.gov/study/NCT02187120
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Trial related presentations / publications
Gruen RL, Jacobs IG, Reade MC; PATCH-Trauma study. Trauma and tranexamic acid. Med J Aust. 2013 Sep 2;199(5):310-1. doi: 10.5694/mja13.10747. No abstract available. Reade MC, Pitt V, Gruen RL. Tranexamic acid and trauma: current status and knowledge gaps with recommended research priorities. Shock. 2013 Aug;40(2):160-1. doi: 10.1097/SHK.0b013e31829ab240. No abstract available. Mitra B, Mazur S, Cameron PA, Bernard S, Burns B, Smith A, Rashford S, Fitzgerald M, Smith K, Gruen RL; PATCH-Trauma Study Investigators. Tranexamic acid for trauma: filling the 'GAP' in evidence. Emerg Med Australas. 2014 Apr;26(2):194-7. doi: 10.1111/1742-6723.12172. Gruen RL, Mitra B. Tranexamic acid for trauma. Lancet. 2011 Mar 26;377(9771):1052-4. doi: 10.1016/S0140-6736(11)60396-6. No abstract available. Mitra B, Cameron PA, Mori A, Maini A, Fitzgerald M, Paul E, Street A. Early prediction of acute traumatic coagulopathy. Resuscitation. 2011 Sep;82(9):1208-13. doi: 10.1016/j.resuscitation.2011.04.007. Epub 2011 Apr 21. Mitra B, Bernard S, Gantner D, Burns B, Reade MC, Murray L, Trapani T, Pitt V, McArthur C, Forbes A, Maegele M, Gruen RL; PATCH-Trauma study investigators; PATCH-Trauma Study investigators. Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial. BMJ Open. 2021 Mar 15;11(3):e046522. doi: 10.1136/bmjopen-2020-046522.
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Public notes
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Contacts
Principal investigator
Name
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Russell L Gruen, MBBS PhD
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02187120
Download to PDF