Clinical trial NCT02593877: Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemorrhage
Coagulopathy
Trauma
Keywords: Trauma
Hemostasis
Resuscitation
Coagulopathy
Transfusion
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Klinikum der Universität Köln
name: Rigshospitalet, Denmark
name: Oxford University Hospitals NHS Trust
name: Barts & The London NHS Trust
name: European Commission
First posted: 2015-11-01
Enrollment: 412
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects alive and free of massive transfusion
timeFrame: 24 hours
Secondary outcomes:
measure: 6hr Mortality
timeFrame: 6 hours
measure: 24hr Mortality
timeFrame: 24 hours
measure: 28d Mortality
timeFrame: 28-days
measure: 90d Mortality
timeFrame: 90-days
measure: Duration of coagulopathy
timeFrame: 28-days post admission
measure: Severity of coagulopathy
timeFrame: 28-days post admission
measure: Proportion of patients with corrected coagulopathy after first 8U RBC
timeFrame: 28-days post admission
measure: Time to hemostasis
timeFrame: 28-days post admission
measure: Time spent in coagulopathic condition until haemostasis
timeFrame: 28-days post admission
measure: 6hr Blood products transfused
timeFrame: 6 hours
measure: 24hr Blood products transfused
timeFrame: 24 hours
measure: 28d Ventilator-free days
timeFrame: 28 days
measure: 28d ICU-free days
timeFrame: 28 days
measure: Length of stay
timeFrame: 28 days
measure: Symptomatic thromboembolic events
timeFrame: 28 days
measure: Transfusion-related complications
timeFrame: 28-days
measure: Organ dysfunction
timeFrame: 28-days
measure: 28d/discharge QoL
timeFrame: 28 days
measure: 90d QoL
timeFrame: 90 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Cologne
country: Germany
facility: Kliniken der Stadt Köln gGmbH
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
city: Oslo
country: Norway
facility: Oslo University Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
state: Greater London
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Queen Mary University of London, Barts Health NHS Trust
name: Karim Brohi, FCRS FRCA
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Christine Gaarder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baksaas-Aasen K, Gall L, Eaglestone S, Rourke C, Juffermans NP, Goslings JC, Naess PA, van Dieren S, Ostrowski SR, Stensballe J, Maegele M, Stanworth SJ, Gaarder C, Brohi K, Johansson PI. iTACTIC - implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a multicentre, randomised controlled trial. Trials. 2017 Oct 18;18(1):486. doi: 10.1186/s13063-017-2224-9.