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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)
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.
Secondary ID [1] 0 0
U1111-1160-6738
Secondary ID [2] 0 0
APP1044894
Universal Trial Number (UTN)
Trial acronym
PATCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wounds and Injuries 0 0
Acute Coagulopathy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Units of blood products used (red blood cells, plasma, platelets, prothrombin complex concentrate, fibrinogen, Factor VIIa, cryoprecipitate)
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Coagulation assessed using the international normalised ratio (INR)
Timepoint [2] 0 0
Immediately upon patient arrival to hospital
Secondary outcome [3] 0 0
Coagulation assessed using the international normalised ratio (INR)
Timepoint [3] 0 0
At the end of 8 hour infusion of study drug
Secondary outcome [4] 0 0
Coagulation assessed using the international normalised ratio (INR)
Timepoint [4] 0 0
24 hours after pre-hospital dose of study drug
Secondary outcome [5] 0 0
Coagulation assessed by activated partial thromboplastin time (APTT)
Timepoint [5] 0 0
Immediately upon patient arrival to hospital
Secondary outcome [6] 0 0
Coagulation assessed by activated partial thromboplastin time (APTT)
Timepoint [6] 0 0
At the end of 8 hour infusion of study drug
Secondary outcome [7] 0 0
Coagulation assessed by activated partial thromboplastin time (APTT)
Timepoint [7] 0 0
24 hours after pre-hospital dose of study drug
Secondary outcome [8] 0 0
Platelet count
Timepoint [8] 0 0
Immediately upon patient arrival to hospital
Secondary outcome [9] 0 0
Platelet count
Timepoint [9] 0 0
At the end of 8 hour infusion of study drug
Secondary outcome [10] 0 0
Platelet count
Timepoint [10] 0 0
24 hours after pre-hospital dose of study drug
Secondary outcome [11] 0 0
Vascular occlusive events (myocardial infarction, stroke, deep venous thrombosis (DVT), pulmonary embolus (PE))
Timepoint [11] 0 0
Hospital discharge (or up to 28 days in hospital)
Secondary outcome [12] 0 0
Ventilator-free days
Timepoint [12] 0 0
28 days
Secondary outcome [13] 0 0
Mortality
Timepoint [13] 0 0
24 hours
Secondary outcome [14] 0 0
Mortality
Timepoint [14] 0 0
28 days
Secondary outcome [15] 0 0
Mortality
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
Timepoint [16] 0 0
24 hours
Secondary outcome [17] 0 0
Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
Timepoint [17] 0 0
28 days
Secondary outcome [18] 0 0
Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
Timepoint [18] 0 0
6 months
Secondary outcome [19] 0 0
Cumulative incidence of sepsis
Timepoint [19] 0 0
Hospital discharge (or up to 28 days in hospital)
Secondary outcome [20] 0 0
Quality of life measured using WHODAS 2.0
Timepoint [20] 0 0
6 months
Secondary outcome [21] 0 0
Quality of life measured using the EuroQOL 5 dimensions questionnaire (EQ-5D)
Timepoint [21] 0 0
6 months
Secondary outcome [22] 0 0
Number of participants with serious adverse events
Timepoint [22] 0 0
hospital discharge (or up to 28 days in hospital)
Secondary outcome [23] 0 0
Coagulation assessed by fibrinogen
Timepoint [23] 0 0
Immediately upon patient arrival to hospital
Secondary outcome [24] 0 0
Coagulation assessed by fibrinogen
Timepoint [24] 0 0
At the end of 8 hour infusion of study drug
Secondary outcome [25] 0 0
Coagulation assessed by fibrinogen
Timepoint [25] 0 0
24 hours after pre-hospital dose of study drug

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]
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Suspected pregnancy
* Nursing home residents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/09/2022
Sample size
Target
Accrual to date
Final
1310
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [2] 0 0
NNSW Medical Retrieval Service - Lismore
Recruitment hospital [3] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [4] 0 0
CareFlight - Northmead
Recruitment hospital [5] 0 0
Orange Base Hospital - Orange
Recruitment hospital [6] 0 0
Ambulance Service of New South Wales - Rozelle
Recruitment hospital [7] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [9] 0 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [10] 0 0
Westmead Hospital - Westmead
Recruitment hospital [11] 0 0
St John Ambulance - Darwin
Recruitment hospital [12] 0 0
Royal Darwin Hospital - Darwin
Recruitment hospital [13] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [14] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [15] 0 0
Gold Coast Hospital - Gold Coast
Recruitment hospital [16] 0 0
Queensland Ambulance Service - Kedron
Recruitment hospital [17] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [18] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [19] 0 0
South Australia Ambulance Service - Eastwood
Recruitment hospital [20] 0 0
Ambulance Tasmania - Hobart
Recruitment hospital [21] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [22] 0 0
Ambulance Victoria - Melbourne
Recruitment hospital [23] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [24] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [25] 0 0
St John Ambulance Western Australia - Geraldton
Recruitment hospital [26] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2152 - Northmead
Recruitment postcode(s) [4] 0 0
2800 - Orange
Recruitment postcode(s) [5] 0 0
2039 - Rozelle
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2170 - Sydney
Recruitment postcode(s) [8] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment postcode(s) [10] 0 0
0810 - Darwin
Recruitment postcode(s) [11] 0 0
0811 - Darwin
Recruitment postcode(s) [12] 0 0
4006 - Brisbane
Recruitment postcode(s) [13] 0 0
4102 - Brisbane
Recruitment postcode(s) [14] 0 0
4215 - Gold Coast
Recruitment postcode(s) [15] 0 0
4031 - Kedron
Recruitment postcode(s) [16] 0 0
5000 - Adelaide
Recruitment postcode(s) [17] 0 0
5042 - Bedford Park
Recruitment postcode(s) [18] 0 0
5063 - Eastwood
Recruitment postcode(s) [19] 0 0
7000 - Hobart
Recruitment postcode(s) [20] 0 0
2000 - Melbourne
Recruitment postcode(s) [21] 0 0
3004 - Melbourne
Recruitment postcode(s) [22] 0 0
3050 - Melbourne
Recruitment postcode(s) [23] 0 0
6530 - Geraldton
Recruitment postcode(s) [24] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Albany
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton West
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hastings
Country [5] 0 0
New Zealand
State/province [5] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Health Research Council, New Zealand
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02187120
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.
Public notes

Contacts
Principal investigator
Name 0 0
Russell L Gruen, MBBS PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02187120