Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy

Summary

This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst the other half will receive massive transfusion protocol resuscitation using conventional coagulation tests.

Conditions

• Hemorrhage
• Coagulopathy
• Trauma

Interventions

DEVICE

VHA algorithm

Analysis of more than 2,200 trauma subjects has enabled the definition of clinically-relevant VHA thresholds (i.e. ROTEM® and TEG® parameters) and patterns by which it is possible to rapidly identify coagulopathic patients and anticipate the need for massive transfusion. These threshold parameters have been defined and applied to the generation of an evidence-based targeted treatment algorithm (i.e. the Intervention)

Sponsors & Collaborators

• Oslo University Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Klinikum der Universität Köln

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• European Commission

  collaborator OTHER

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Karim Brohi, FCRS FRCA · Queen Mary University of London, Barts Health NHS Trust

• Christine Gaarder, MD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-01

Primary Completion

2018-07-03

Completion

2018-07-30

Countries

• Denmark
• Germany
• Netherlands
• Norway
• United Kingdom

Study Locations