Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study)
NCT ID: NCT02187120
Last Updated: 2023-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1310 participants
INTERVENTIONAL
2014-07-28
2022-09-07
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
Placebo
Interventions
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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.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \[Yes = 1, No = 0\]
Exclusion Criteria
* Nursing home residents
18 Years
ALL
No
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Health Research Council, New Zealand
OTHER
Monash University
OTHER
Responsible Party
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Russell Gruen
Professor of Surgery and Public Health
Principal Investigators
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Russell L Gruen, MBBS PhD
Role: PRINCIPAL_INVESTIGATOR
Monash University
Locations
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Lismore Base Hospital
Lismore, New South Wales, Australia
NNSW Medical Retrieval Service
Lismore, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
CareFlight
Northmead, New South Wales, Australia
Orange Base Hospital
Orange, New South Wales, Australia
Ambulance Service of New South Wales
Rozelle, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Wagga Wagga Base Hospital
Wagga Wagga, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
St John Ambulance
Darwin, Northern Territory, Australia
Royal Darwin Hospital
Darwin, Northern Territory, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Gold Coast Hospital
Gold Coast, Queensland, Australia
Queensland Ambulance Service
Kedron, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
South Australia Ambulance Service
Eastwood, South Australia, Australia
Ambulance Tasmania
Hobart, Tasmania, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Ambulance Victoria
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
St John Ambulance Western Australia
Geraldton, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
St John Ambulance
Albany, , New Zealand
Auckland City Hospital
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Waikato Hospital
Hamilton West, , New Zealand
Hawke's Bay
Hastings, , New Zealand
Wellington Free Ambulance
Wellington, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Countries
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References
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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, 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.
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.
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.
Related Links
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PATCH study website
Other Identifiers
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U1111-1160-6738
Identifier Type: OTHER
Identifier Source: secondary_id
APP1044894
Identifier Type: -
Identifier Source: org_study_id
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