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Completed

NCT Number: NCT02187120

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

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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Key information

Conditions

Wounds and Injuries Acute Coagulopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lismore Base Hospital, Lismore, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]

Exclusion criteria

  • Suspected pregnancy
  • Nursing home residents

Treatment and study plan

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.

Other names: Cyklokapron

Placebo

Drug

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).

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 24 hours

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

    Time frame: Immediately upon patient arrival to hospital

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

    Time frame: At the end of 8 hour infusion of study drug

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

    Time frame: 24 hours after pre-hospital dose of study drug

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

    Time frame: Immediately upon patient arrival to hospital

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

    Time frame: At the end of 8 hour infusion of study drug

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

    Time frame: 24 hours after pre-hospital dose of study drug

  8. Platelet count

    Time frame: Immediately upon patient arrival to hospital

  9. Platelet count

    Time frame: At the end of 8 hour infusion of study drug

  10. Platelet count

    Time frame: 24 hours after pre-hospital dose of study drug

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

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

  12. Ventilator-free days

    Time frame: 28 days

  13. Mortality

    Time frame: 24 hours

  14. Mortality

    Time frame: 28 days

  15. Mortality

    Time frame: 6 months

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

    Time frame: 24 hours

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

    Time frame: 28 days

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

    Time frame: 6 months

  19. Cumulative incidence of sepsis

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

  20. Quality of life measured using WHODAS 2.0

    Time frame: 6 months

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

    Time frame: 6 months

  22. Number of participants with serious adverse events

    Time frame: hospital discharge (or up to 28 days in hospital)

  23. Coagulation assessed by fibrinogen

    Time frame: Immediately upon patient arrival to hospital

  24. Coagulation assessed by fibrinogen

    Time frame: At the end of 8 hour infusion of study drug

  25. Coagulation assessed by fibrinogen

    Time frame: 24 hours after pre-hospital dose of study drug

Other outcomes

  1. Blood lactate concentration

    Time frame: Immediately upon patient arrival to hospital

  2. Laboratory analysis of fibrinolytic activity

    Time frame: At the end of 8 hour infusion of study drug

  3. Laboratory analysis of fibrinolytic activity

    Time frame: 24 hours after first (prehospital) dose of study drug

  4. Laboratory analysis of plasmin/anti-plasmin complexes

    Time frame: At the end of 8 hour infusion of study drug

  5. Laboratory analysis of plasmin/anti-plasmin complexes

    Time frame: 24 hours after first (pre-hospital) dose of study drug

  6. Laboratory analysis of tissue type plasminogen activator (tPA)

    Time frame: At the end of 8 hour infusion of study drug

  7. Laboratory analysis of tissue type plasminogen activator (tPA)

    Time frame: 24 hours after first (pre-hospital) dose of study drug

  8. Laboratory analysis of plasminogen activator inhibitor 1 (PAI-1)

    Time frame: At the end of 8 hour infusion of study drug

  9. Laboratory analysis of plasminogen activator inhibitor 1 (PAI-1)

    Time frame: 24 hours after first (pre-hospital) dose of study drug

  10. Laboratory analysis of t-PA/PAI-1 complexes

    Time frame: At the end of 8 hour infusion of study drug

    Substudy

  11. Laboratory analysis of t-PA/PAI-1 complexes

    Time frame: 24 hours after first (pre-hospital) dose of study drug

    Substudy

  12. Laboratory analysis of thrombin activatable fibrinolysis inhibitor (TAFI)

    Time frame: At the end of 8 hour infusion of study drug

    Substudy

  13. Laboratory analysis of thrombin activatable fibrinolysis inhibitor (TAFI)

    Time frame: 24 hours after first (pre-hospital) dose of study drug

    Substudy

  14. Laboratory analysis of interleukins (IL-2, IL-4, IL-6, IL-8, IL-10)

    Time frame: At the end of 8 hour infusion of study drug

    Substudy

  15. Laboratory analysis of interleukins (IL-2, IL-4, IL-6, IL-8, IL-10)

    Time frame: 24 hours after first (pre-hospital) dose of study drug

    Substudy

  16. Laboratory analysis of granulocyte macrophage colony-stimulating factor (GM-CSF)

    Time frame: At the end of 8 hour infusion of study drug

    Substudy

  17. Laboratory analysis of granulocyte macrophage colony-stimulating factor (GM-CSF)

    Time frame: 24 hours after first (pre-hospital) dose of study drug

    Substudy

  18. Laboratory analysis of interferon gamma

    Time frame: At the end of 8 hour infusion of study drug

    Substudy

  19. Laboratory analysis of interferon gamma

    Time frame: 24 hours after first (pre-hospital) dose of study drug

    Substudy

  20. Laboratory analysis of tumour necrosis factor alpha

    Time frame: At the end of 8 hour infusion of study drug

    Substudy

  21. Laboratory analysis of tumour necrosis factor alpha

    Time frame: 24 hours after first (pre-hospital) dose of study drug

    Substudy

  22. TXA concentration in blood

    Time frame: 8 hours after first dose of study drug

    substudy

  23. TXA concentration in blood

    Time frame: 24 hours after first dose of study drug

    substudy

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Health Research Council, New Zealand
  • National Health and Medical Research Council, Australia

Registry information

Official study 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.

Acronym: PATCH

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2014
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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