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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1160-6738 | Other Identifier | WHO Universal Trial Number (UTN) |
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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| Health Research Council, New Zealand | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Units of blood products used (red blood cells, plasma, platelets, prothrombin complex concentrate, fibrinogen, Factor VIIa, cryoprecipitate) | 24 hours | |
| Coagulation assessed using the international normalised ratio (INR) | Immediately upon patient arrival to hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lactate concentration | Immediately upon patient arrival to hospital | |
| Laboratory analysis of fibrinolytic activity | At the end of 8 hour infusion of study drug | |
Inclusion Criteria:
COAST score
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell L Gruen, MBBS PhD | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lismore Base Hospital | Lismore | New South Wales | 2480 | Australia | ||
| NNSW Medical Retrieval Service |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23992173 | Background | 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. | |
| 23860584 | Background | 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. |
| Label | URL |
|---|---|
| PATCH study website | View source |
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| Placebo | Drug |
|
| Coagulation assessed using the international normalised ratio (INR) | At the end of 8 hour infusion of study drug |
| Coagulation assessed using the international normalised ratio (INR) | 24 hours after pre-hospital dose of study drug |
| Coagulation assessed by activated partial thromboplastin time (APTT) | Immediately upon patient arrival to hospital |
| Coagulation assessed by activated partial thromboplastin time (APTT) | At the end of 8 hour infusion of study drug |
| Coagulation assessed by activated partial thromboplastin time (APTT) | 24 hours after pre-hospital dose of study drug |
| Platelet count | Immediately upon patient arrival to hospital |
| Platelet count | At the end of 8 hour infusion of study drug |
| Platelet count | 24 hours after pre-hospital dose of study drug |
| Vascular occlusive events (myocardial infarction, stroke, deep venous thrombosis (DVT), pulmonary embolus (PE)) | Hospital discharge (or up to 28 days in hospital) |
| Ventilator-free days | 28 days |
| Mortality | 24 hours |
| Mortality | 28 days |
| Mortality | 6 months |
| Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury | 24 hours |
| Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury | 28 days |
| Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury | 6 months |
| Cumulative incidence of sepsis | Hospital discharge (or up to 28 days in hospital) |
| Quality of life measured using WHODAS 2.0 | 6 months |
| Quality of life measured using the EuroQOL 5 dimensions questionnaire (EQ-5D) | 6 months |
| Number of participants with serious adverse events | hospital discharge (or up to 28 days in hospital) |
| Coagulation assessed by fibrinogen | Immediately upon patient arrival to hospital |
| Coagulation assessed by fibrinogen | At the end of 8 hour infusion of study drug |
| Coagulation assessed by fibrinogen | 24 hours after pre-hospital dose of study drug |
| Laboratory analysis of fibrinolytic activity |
| 24 hours after first (prehospital) dose of study drug |
| Laboratory analysis of plasmin/anti-plasmin complexes | At the end of 8 hour infusion of study drug |
| Laboratory analysis of plasmin/anti-plasmin complexes | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of tissue type plasminogen activator (tPA) | At the end of 8 hour infusion of study drug |
| Laboratory analysis of tissue type plasminogen activator (tPA) | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of plasminogen activator inhibitor 1 (PAI-1) | At the end of 8 hour infusion of study drug |
| Laboratory analysis of plasminogen activator inhibitor 1 (PAI-1) | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of t-PA/PAI-1 complexes | Substudy | At the end of 8 hour infusion of study drug |
| Laboratory analysis of t-PA/PAI-1 complexes | Substudy | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of thrombin activatable fibrinolysis inhibitor (TAFI) | Substudy | At the end of 8 hour infusion of study drug |
| Laboratory analysis of thrombin activatable fibrinolysis inhibitor (TAFI) | Substudy | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of interleukins (IL-2, IL-4, IL-6, IL-8, IL-10) | Substudy | At the end of 8 hour infusion of study drug |
| Laboratory analysis of interleukins (IL-2, IL-4, IL-6, IL-8, IL-10) | Substudy | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of granulocyte macrophage colony-stimulating factor (GM-CSF) | Substudy | At the end of 8 hour infusion of study drug |
| Laboratory analysis of granulocyte macrophage colony-stimulating factor (GM-CSF) | Substudy | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of interferon gamma | Substudy | At the end of 8 hour infusion of study drug |
| Laboratory analysis of interferon gamma | Substudy | 24 hours after first (pre-hospital) dose of study drug |
| Laboratory analysis of tumour necrosis factor alpha | Substudy | At the end of 8 hour infusion of study drug |
| Laboratory analysis of tumour necrosis factor alpha | Substudy | 24 hours after first (pre-hospital) dose of study drug |
| TXA concentration in blood | substudy | 8 hours after first dose of study drug |
| TXA concentration in blood | substudy | 24 hours after first dose of study drug |
| Lismore |
| New South Wales |
| 2480 |
| Australia |
| John Hunter Hospital | Newcastle | New South Wales | 2305 | Australia |
| CareFlight | Northmead | New South Wales | 2152 | Australia |
| Orange Base Hospital | Orange | New South Wales | 2800 | Australia |
| Ambulance Service of New South Wales | Rozelle | New South Wales | 2039 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Liverpool Hospital | Sydney | New South Wales | 2170 | Australia |
| Wagga Wagga Base Hospital | Wagga Wagga | New South Wales | 2650 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| St John Ambulance | Darwin | Northern Territory | 0810 | Australia |
| Royal Darwin Hospital | Darwin | Northern Territory | 0811 | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4006 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Gold Coast Hospital | Gold Coast | Queensland | 4215 | Australia |
| Queensland Ambulance Service | Kedron | Queensland | 4031 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| South Australia Ambulance Service | Eastwood | South Australia | 5063 | Australia |
| Ambulance Tasmania | Hobart | Tasmania | 7000 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Ambulance Victoria | Melbourne | Victoria | 2000 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| St John Ambulance Western Australia | Geraldton | Western Australia | 6530 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| St John Ambulance | Albany | 0632 | New Zealand |
| Auckland City Hospital | Auckland | 1142 | New Zealand |
| Middlemore Hospital | Auckland | 2025 | New Zealand |
| Waikato Hospital | Hamilton West | 3204 | New Zealand |
| Hawke's Bay | Hastings | 4156 | New Zealand |
| Wellington Free Ambulance | Wellington | 6011 | New Zealand |
| Wellington Hospital | Wellington | 6021 | New Zealand |
| 24708011 | Background | 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. |
| 21439636 | Background | 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. |
| 21600687 | Background | 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. |
| 41039456 | Derived | Mitra B, Reade MC, Bernard S, Dicker B, Maegele M, Gruen RL. High ratio of plasma to red cells in contemporary resuscitation of haemorrhagic shock after trauma: a secondary analysis of the PATCH-trauma trial. Scand J Trauma Resusc Emerg Med. 2025 Oct 2;33(1):154. doi: 10.1186/s13049-025-01476-2. |
| 37314244 | Derived | PATCH-Trauma Investigators and the ANZICS Clinical Trials Group; Gruen RL, Mitra B, Bernard SA, McArthur CJ, Burns B, Gantner DC, Maegele M, Cameron PA, Dicker B, Forbes AB, Hurford S, Martin CA, Mazur SM, Medcalf RL, Murray LJ, Myles PS, Ng SJ, Pitt V, Rashford S, Reade MC, Swain AH, Trapani T, Young PJ. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023 Jul 13;389(2):127-136. doi: 10.1056/NEJMoa2215457. Epub 2023 Jun 14. |
| 33722875 | Derived | 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. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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