NCT02593877

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

October 15, 2015

Last Update Submit

August 28, 2018

Conditions

HemorrhageCoagulopathyTrauma

Keywords

TraumaHemostasisResuscitationCoagulopathyTransfusion

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 hours

Secondary Outcomes (19)

  • 6hr Mortality

    6 hours

  • 24hr Mortality

    24 hours

  • 28d Mortality

    28-days

  • 90d Mortality

    90-days

  • Duration of coagulopathy

    28-days post admission

  • +14 more secondary outcomes

Study Arms (2)

VHA algorithm

EXPERIMENTAL

Massive transfusion protocol resuscitation aiming at ratio 1:1:1 of blood components (RBC 1: plasma 1: platelets 1) and VHA-guiding further resuscitation with blood products and procoagulant factors

Device: VHA algorithm

Control

NO INTERVENTION

Massive transfusion protocol resuscitation aiming at ratio 1:1:1 of blood components (RBC 1: plasma 1: platelets 1) and conventional coagulation tests guiding further resuscitation with blood products and procoagulant factors

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)

VHA algorithm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Copenhagen University Hospital

Copenhagen, Denmark

Location

Kliniken der Stadt Köln gGmbH

Cologne, Germany

Location

Academic Medical Centre

Amsterdam, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

The Royal London Hospital

London, Greater London, E1 1BB, United Kingdom

Location

Queens Medical Centre

Nottingham, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29047413DERIVED

MeSH Terms

Conditions

HemorrhageHemostatic DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Karim Brohi, FCRS FRCA

    Queen Mary University of London, Barts Health NHS Trust

    STUDY DIRECTOR

  • Christine Gaarder, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

November 2, 2015

Study Start

June 1, 2016

Primary Completion

July 3, 2018

Study Completion

July 30, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)GB(3)DK(1)DE(1)NL(1)