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

Phase 3

Completed

• Conditions: Acute Coagulopathy; Wounds and Injuries
• Interventions: Drug: Tranexamic Acid; Drug: Placebo

• Registration Number: NCT02187120
• Lead Sponsor: Monash University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-10
• Study Start: 2014-07-28
• Primary Completion: 2022-05-09
• Study Completion: 2022-09-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Coagulation assessed by fibrinogen	24 hours after pre-hospital dose of study drug
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)	24 hours after pre-hospital dose of study drug
Platelet count	24 hours after pre-hospital dose of study drug
Number of participants with serious adverse events	hospital discharge (or up to 28 days in hospital)
Quality of life measured using the EuroQOL 5 dimensions questionnaire (EQ-5D)	6 months
Coagulation assessed by activated partial thromboplastin time (APTT)	24 hours after pre-hospital dose of study drug
Mortality	6 months
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

Trial Locations

Locations (32)

South Australia Ambulance Service; 🇦🇺 Eastwood, South Australia, Australia

St John Ambulance; 🇳🇿 Albany, New Zealand

NNSW Medical Retrieval Service; 🇦🇺 Lismore, New South Wales, Australia

Gold Coast Hospital; 🇦🇺 Gold Coast, Queensland, Australia

John Hunter Hospital; 🇦🇺 Newcastle, New South Wales, Australia

Queensland Ambulance Service; 🇦🇺 Kedron, Queensland, Australia

Lismore Base Hospital; 🇦🇺 Lismore, New South Wales, Australia

CareFlight; 🇦🇺 Northmead, New South Wales, Australia

Royal Hobart Hospital; 🇦🇺 Hobart, Tasmania, Australia

Waikato Hospital; 🇳🇿 Hamilton West, New Zealand

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Ambulance Tasmania; 🇦🇺 Hobart, Tasmania, Australia

Wellington Free Ambulance; 🇳🇿 Wellington, New Zealand

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia

Orange Base Hospital; 🇦🇺 Orange, New South Wales, Australia

Ambulance Service of New South Wales; 🇦🇺 Rozelle, New South Wales, Australia

Wellington Hospital; 🇳🇿 Wellington, New Zealand

Liverpool Hospital; 🇦🇺 Sydney, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Ambulance Victoria; 🇦🇺 Melbourne, Victoria, Australia

Wagga Wagga Base Hospital; 🇦🇺 Wagga Wagga, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Queensland, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Middlemore Hospital; 🇳🇿 Auckland, New Zealand

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia

St John Ambulance Western Australia; 🇦🇺 Geraldton, Western Australia, Australia

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Hawke's Bay; 🇳🇿 Hastings, New Zealand

Royal Darwin Hospital; 🇦🇺 Darwin, Northern Territory, Australia