Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study)

NCT02187120 | Completed Phase 3 DMC

• 2 other identifiers: APP1044894U1111-1160-6738
• Study Type: interventional
• Target: 1,310
• Locations: 2 countries
• Sites: 33

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.

Conditions

Wounds and Injuries; Acute Coagulopathy

Keywords

Wounds and Injuries; Acute Coagulopathy; Tranexamic Acid; Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (25)

• 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

• 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

Other Outcomes (23)

• Blood lactate concentration

  Immediately upon patient arrival to hospital

• Laboratory analysis of fibrinolytic activity

  At the end of 8 hour infusion of study drug

• Laboratory analysis of fibrinolytic activity

  24 hours after first (prehospital) dose of study drug

Study Arms (2)

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.

Drug: Tranexamic Acid

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.

Drug: Placebo

Interventions

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.

Also known as: Cyklokapron

Tranexamic Acid

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Yes = 1, No = 0\]

You may not qualify if:

• Suspected pregnancy
• Nursing home residents

Sponsors & Collaborators

• Monash University: lead
• National Health and Medical Research Council, Australia: collaborator
• Health Research Council, New Zealand: collaborator

Study Sites (33)

Lismore Base Hospital

Lismore, New South Wales, 2480, Australia

Location

NNSW Medical Retrieval Service

Lismore, New South Wales, 2480, Australia

Location

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

Location

CareFlight

Northmead, New South Wales, 2152, Australia

Location

Orange Base Hospital

Orange, New South Wales, 2800, Australia

Location

Ambulance Service of New South Wales

Rozelle, New South Wales, 2039, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

Location

Wagga Wagga Base Hospital

Wagga Wagga, New South Wales, 2650, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

St John Ambulance

Darwin, Northern Territory, 0810, Australia

Location

Royal Darwin Hospital

Darwin, Northern Territory, 0811, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4006, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Gold Coast Hospital

Gold Coast, Queensland, 4215, Australia

Location

Queensland Ambulance Service

Kedron, Queensland, 4031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

South Australia Ambulance Service

Eastwood, South Australia, 5063, Australia

Location

Ambulance Tasmania

Hobart, Tasmania, 7000, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Ambulance Victoria

Melbourne, Victoria, 2000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

St John Ambulance Western Australia

Geraldton, Western Australia, 6530, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

St John Ambulance

Albany, 0632, New Zealand

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Middlemore Hospital

Auckland, 2025, New Zealand

Location

Waikato Hospital

Hamilton West, 3204, New Zealand

Location

Hawke's Bay

Hastings, 4156, New Zealand

Location

Wellington Free Ambulance

Wellington, 6011, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Related Publications (8)

• 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.

  PMID: 23992173 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.

  PMID: 23860584 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.

  PMID: 24708011 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.

  PMID: 21439636 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.

  PMID: 21600687 BACKGROUND

• 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.

  PMID: 41039456 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.

  PMID: 37314244 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.

  PMID: 33722875 DERIVED

Related Links

• PATCH study website

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Russell L Gruen, MBBS PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Public Health

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 10, 2014
• Study Start: July 28, 2014
• Primary Completion: May 9, 2022
• Study Completion: September 7, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

AU (26); NZ (7)