As a translational research centre, all C4TS research is ultimately aimed at moving findings 'from the bench to the bedside', and clinical trials are a crucial step along the way.
The Clinical Trials Unit (CTU) supports C4TS with all aspects of clinical trial planning, set up, conduct, analysis and publication. We are also able to provide a CTU service for other institutions interested in conducting trials in bleeding, multiple organ dysfunction post-injury, and elderly trauma.
CRYOSTAT-2 was a NIHR (HTA) and Bart's Charity funded trial to test whether giving early high dose cryoprecipitate to replace fibrinogen (a key clotting factor that is found to be low in bleeding trauma patients) reduced deaths after major haemorrhage. The study enrolled 1600 severely injured with life-threatening bleeding across the UK and in the USA, between 2017 and 2022. To our surprise, overall, there was no difference in mortality between those patients who got high dose cryoprecipitate and those who received standard of care. However, these results do fit with our current thinking that one-size fits all does not work for trauma patients, and we need to bring early diagnostic tests close to the patient to allow more precision approaches to treating severe bleeding.
The 5-year TACTIC project is a multi-component study, a main focus of which is the development of a European-wide clinical trial entitled “Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy (iTACTIC)”. iTACTIC is designed to find out if a rapid, detailed blood clotting test called Viscoelastic Haemostatic Assays (VHA) can be used to identify Trauma Induced Coagulopathy (TIC) early and to guide a Massive Transfusion Protocol (MTP) for that individual patient’s needs. The study will compare the outcomes of patients treated using the conventional blood transfusion strategy with the outcomes of patients treated using a personalised blood transfusion strategy guided by VHA.
Artesunate is a drug that has been in use for many years as is the treatment of choice for severe malaria.The drug appears to be enhancing the protection of organs by reducing the body’s excessive response (i.e. inflammation) to injury and blood loss, and by activating well-known cell-survival pathways. Having made this discovery in the laboratory, C4TS are preparing to conduct a Phase 2a clinical trial to test the safety and potential efficacy of Artesunate treatment in trauma patients suffering severe haemorrhage.
