The 5-year TACTIC project was a multi-component study, a main focus of which was the development of a European-wide clinical trial, entitled “Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy (iTACTIC)”.

Background

Currently, severely injured and bleeding patients are resuscitated with transfused blood products following a Massive Transfusion Protocol (MTP) in place in each hospital.  A MTP aims to replace the different components found within the blood that have been lost and to assist the injured patient in making adequate blood clots to prevent further bleeding.  A MTP uses conventional hospital laboratory tests of blood clotting to guide therapy.

In one quarter of bleeding trauma patients, the ability to form adequate blood clots is lost.  This condition is termed Trauma Induced Coagulopathy (TIC). C4TS has been undertaking pioneering research into TIC for many years. Studies such as ACIT and TACTIC  have been exploring the clinically significant mechanisms by which the body’s inflammation and coagulation pathways are activated immediately following major trauma, with a view to improving diagnosis and treatment of TIC.

Our research to date has shown that that patients with TIC have worse outcomes, but current MTPs fail to detect TIC early or correct it during major bleeding.

iTACTIC was designed to find out if a rapid, detailed blood clotting test called Viscoelastic Haemostatic Assays (VHA) can be used to identify TIC early and to guide a MTP for that individual patient’s needs. The study compared 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.

Objectives

The TACTIC consortium set-up and conducted a prospective, exploratory randomized control trial comparing the effect of patient-matched haemostatic resuscitation, using a viscoelastic haemostatic assay (VHA) led treatment versus local empiric ‘massive transfusion protocol’ (MTP) treatment. The objectives were to:

  • Assess the potential clinical efficacy of VHA led treatment in correction of Trauma Induced Coagulopathy (TIC) on patient outcomes
  • Define potential resource use, costs and cost-effectiveness of adopting a VHA-led transfusion therapy in the management of trauma haemorrhage
  • Assess the performance of a risk stratification model in identifying coagulopathic patients in the Emergency Department and preventing unnecessary transfusion

Study participants

400 trauma patients were recruited to iTACTIC across the following sites:

  • The Royal London Hospital (UK)
  • John Radcliffe Hospital (Oxford, UK)
  • Oslo University Hospital (Norway)
  • Kliniken der Stadt (Cologne, Germany)
  • Academic Medical Centre (Amsterdam)
  • Rigshospitalet (Copenhagen University Hospital, Denmark)

iTACTIC PROTOCOL SUMMARY

CLINICAL TRIALS GOV IDENTIFIER: NCT02593877

TITLE: A multi-centre, prospective, randomized controlled study to compare outcomes of viscoelastic haemostatic assay (VHA) guided resuscitation versus conventional resuscitation support in haemorrhaging trauma patients.

METHODOLOGY AND DURATION: This is a non-blinded, randomised controlled trial study that will enrol patients over a 24-month period. Patient follow-up, data cleaning & analysis will take a further 9 month. Patients' participation in the study will last a maximum of 28 days.

STUDY LEADS: Chief investigator: Prof Karim Brohi (Centre for Trauma Sciences, Queen Mary University London, UK); Co-investigator: Dr Christine Gaarder (Department of Traumatology, Oslo University Hospital)

PRIMARY OBJECTIVE: The primary objective is to compare the haemostatic effect of VHA guided transfusion strategy versus optimized non-VHA guided transfusion strategy in haemorrhaging trauma patients. 

SECONDARY OBJECTIVES: The secondary objectives of the study are to determine the effects of VHA-led versus optimized non-VHA guided resuscitation on organ failure, hospital stay, critical care stay, health care resource needs and mortality.

PHASE OF THE TRIAL: Phase 2a 

NUMBER OF SUBJECTS: A total target of 392 adult male and female severely injured trauma patients with ongoing traumatic haemorrhage.

INCLUSION CRITERIA: A patient will be eligible for the study if they are:

  • Adult trauma patients (according to local definitions)
  • Present with haemorrhagic shock (as defined by HR>100 b/min and/or systolic BP and activate the local massive transfusion protocol) at any time from the time of injury until admission to the emergency department of the participating study site
  • Randomised within 3 hours of injury and 1 hour of admission to the emergency department of the participating study site
  • Agreement is provided on behalf of incapacitated patients by Personal Consultee or Nominated Consultee (i.e. trauma team leader) 

Start Date: 1st February 2016

PATIENT INFORMATION SHEET

As patients were invited to participate in this study, they were provided with an information sheet that helped them understand why the research was being carried out and what it involved.

You can download the patient information sheet here.

TRIAL STATUS

The Royal London Hospital recruited the final patient into the iTACTIC study on July 2nd 2018. Data is being analysed and results are expected to be published in late 2019.

Contact

Clinical Trials Manager: Ms Claire Rourke

 

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