Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy

Queen Mary University of London412 enrolled

Overview

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.

Trauma is the most frequent cause of death in persons aged under 40, with half of these deaths resulting from uncontrolled bleeding. 1 in 4 of all severely injured and shocked patients develop a clotting abnormality termed Trauma Induced Coagulopathy (TIC) within minutes of injury, which causes blood to continue being lost from the body faster than it can be stemmed. Many more injured patients will go on to develop different types of coagulopathy at different times during the course of their treatment, either as a result of their body's ongoing response to trauma or as a consequence of their clinical care. Ultimately coagulopathic patients have increased blood transfusion requirements and suffer more adverse outcomes (e.g. multi organ failure). Current management of coagulopathic, haemorrhaging trauma patients comprises the unguided transfusion of large volumes of red blood cells and clotting product supplements. Without rapidly available and validated diagnostics, products are delivered empirically to patients blind to the type and severity of TIC they may have or indeed even if they do not have TIC. This study will compare outcomes of viscoelastic haemostatic assay (VHA)-guided resuscitation versus conventional management of critically bleeding trauma patients. The hypothesis is that goal-directed haemostatic resuscitation of coagulopathic bleeding trauma patients will yield improved outcomes and reduced blood product demand, compared to empiric massive transfusion therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

412

Conditions

Hemorrhage Coagulopathy Trauma

Interventions

VHA algorithmDEVICE

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)

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: Adult trauma patients (according to local definitions) will be enrolled if they: * Present with hemorrhagic shock at any time from the time of injury until admission to the emergency department (where shock is defined by HR\>100 b/min and/or systolic BP\<90 mmHg) AND activate the local massive transfusion protocol * Randomized within 3 hours of injury and 1 hour of admission to the emergency department * Agreement is provided on behalf of incapacitated patients by Personal Consultee or Nominated Consultee (e.g.trauma team leader) Exclusion Criteria: * Any inclusion criteria are not met

Locations (7)

Copenhagen University Hospital

Copenhagen, Denmark

Kliniken der Stadt Köln gGmbH

Cologne, Germany

Academic Medical Centre

Amsterdam, Netherlands

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Proportion of subjects alive and free of massive transfusion

Proportion of subjects at 24 hours post-admission who are alive and free of massive transfusion (i.e. received 10 or more units of red blood cells within 24 hours)

Time frame: 24 hours

Secondary Outcomes

6hr Mortality

All-cause mortality at 6-hours post admission

Time frame: 6 hours

24hr Mortality

All-cause mortality at 24-hours post admission

Time frame: 24 hours

28d Mortality

All-cause mortality at 28-days post admission

Time frame: 28-days

90d Mortality

All-cause mortality at 90-days post admission

Time frame: 90-days

Duration of coagulopathy

The time spent in coagulopathic state, as defined by Prothrombin Time / International Ratio (PTr) PTr \>1.2) from Admission until the point of hemostasis (itself defined as having occurred at the end of the first hour free of red cell transfusions and the treating clinicians believe primary hemostasis has been achieved).

Time frame: 28-days post admission

Severity of coagulopathy

Defined by the area under the Prothrombin Time / International Ratio (PTr) curve from Admission to the point of haemostasis (where time of hemostasis is defined as having occurred at the end of the first hour free of red cell transfusions and the treating clinicians believe primary hemostasis has been achieved).

Time frame: 28-days post admission

Data from ClinicalTrials.gov

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