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Wounds and InjuriesPhase 3PATCHNCT02187120

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

A Phase 3 study testing Tranexamic Acid in people with Wounds and Injuries and Acute Coagulopathy, run by Monash University at 33 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wounds and Injuries, Acute Coagulopathy
What is being tested?
Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,310 participants
Where
33 sitesin 2 countries
Study dates
28 Jul 2014to 7 Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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]

Who cannot join

  • Suspected pregnancy
  • Nursing home residents

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

Australia26 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4006

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • St John Ambulance

    Darwin, Northern Territory, 0810

  • Royal Darwin Hospital

    Darwin, Northern Territory, 0811

  • South Australia Ambulance Service

    Eastwood, South Australia, 5063

  • St John Ambulance Western Australia

    Geraldton, Western Australia, 6530

  • Gold Coast Hospital

    Gold Coast, Queensland, 4215

  • Ambulance Tasmania

    Hobart, Tasmania, 7000

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Queensland Ambulance Service

    Kedron, Queensland, 4031

  • Lismore Base Hospital

    Lismore, New South Wales, 2480

  • NNSW Medical Retrieval Service

    Lismore, New South Wales, 2480

  • Ambulance Victoria

    Melbourne, Victoria, 2000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • John Hunter Hospital

    Newcastle, New South Wales, 2305

  • CareFlight

    Northmead, New South Wales, 2152

  • Orange Base Hospital

    Orange, New South Wales, 2800

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Ambulance Service of New South Wales

    Rozelle, New South Wales, 2039

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Liverpool Hospital

    Sydney, New South Wales, 2170

  • Wagga Wagga Base Hospital

    Wagga Wagga, New South Wales, 2650

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

New Zealand7 sites

  • St John Ambulance

    Albany, 0632

  • Auckland City Hospital

    Auckland, 1142

  • Middlemore Hospital

    Auckland, 2025

  • Waikato Hospital

    Hamilton West, 3204

  • Hawke's Bay

    Hastings, 4156

  • Wellington Free Ambulance

    Wellington, 6011

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

About this study

Official 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.

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.

Read more

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.

Being tested
Tranexamic Acid, Placebo
Keywords
Wounds and Injuries, Acute Coagulopathy, Tranexamic Acid, Emergency Medical Services
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Also called Cyklokapron

    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.

  • PlaceboDrug

Study groups in NCT02187120
Study groupRoleWhat they receive
Tranexamic AcidExperimentalAs 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.
Receives: Drug: Tranexamic Acid
PlaceboPlacebo comparatorAs 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months

Secondary outcomes (25)

  1. Units of blood products used (red blood cells, plasma, platelets, prothrombin complex concentrate, fibrinogen, Factor VIIa, cryoprecipitate)

    Measured: 24 hours

  2. Coagulation assessed using the international normalised ratio (INR)

    Measured: Immediately upon patient arrival to hospital

  3. Coagulation assessed using the international normalised ratio (INR)

    Measured: At the end of 8 hour infusion of study drug

  4. Coagulation assessed using the international normalised ratio (INR)

    Measured: 24 hours after pre-hospital dose of study drug

  5. Coagulation assessed by activated partial thromboplastin time (APTT)

    Measured: Immediately upon patient arrival to hospital

  6. Coagulation assessed by activated partial thromboplastin time (APTT)

    Measured: At the end of 8 hour infusion of study drug

  7. Coagulation assessed by activated partial thromboplastin time (APTT)

    Measured: 24 hours after pre-hospital dose of study drug

  8. Platelet count

    Measured: Immediately upon patient arrival to hospital

  9. Platelet count

    Measured: At the end of 8 hour infusion of study drug

  10. Platelet count

    Measured: 24 hours after pre-hospital dose of study drug

  11. Vascular occlusive events (myocardial infarction, stroke, deep venous thrombosis (DVT), pulmonary embolus (PE))

    Measured: Hospital discharge (or up to 28 days in hospital)

  12. Ventilator-free days

    Measured: 28 days

  13. Mortality

    Measured: 24 hours

  14. Mortality

    Measured: 28 days

  15. Mortality

    Measured: 6 months

  16. Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury

    Measured: 24 hours

  17. Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury

    Measured: 28 days

  18. Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury

    Measured: 6 months

  19. Cumulative incidence of sepsis

    Measured: Hospital discharge (or up to 28 days in hospital)

  20. Quality of life measured using WHODAS 2.0

    Measured: 6 months

  21. Quality of life measured using the EuroQOL 5 dimensions questionnaire (EQ-5D)

    Measured: 6 months

  22. Number of participants with serious adverse events

    Measured: hospital discharge (or up to 28 days in hospital)

  23. Coagulation assessed by fibrinogen

    Measured: Immediately upon patient arrival to hospital

  24. Coagulation assessed by fibrinogen

    Measured: At the end of 8 hour infusion of study drug

  25. Coagulation assessed by fibrinogen

    Measured: 24 hours after pre-hospital dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2014 (estimated)
  2. Study start28 Jul 2014
  3. Primary completion9 May 2022
  4. Study completion7 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02187120
Sponsor's protocol ID
APP1044894
Other IDs
U1111-1160-6738
Acronym
PATCH
Status last verified
Jan 2023
First submitted
8 Jul 2014
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 23992173

  • 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.

    PubMed 23860584

  • 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.

    PubMed 24708011

  • 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.

    PubMed 21439636

  • 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.

    PubMed 21600687

  • 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.

    PubMed 41039456

  • 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.

    PubMed 37314244

  • 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.

    PubMed 33722875

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic Acid in people with Wounds and Injuries and Acute Coagulopathy, run by Monash University at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187120, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.

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