Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study)
Status:
Recruiting
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Monash University
Collaborators:
Health Research Council, New Zealand National Health and Medical Research Council, Australia