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HemorrhagePhase 2iTACTICNCT02593877

Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy

A Phase 2 study testing VHA algorithm in people with Hemorrhage and Coagulopathy, run by Queen Mary University of London at 7 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Hemorrhage, Coagulopathy, Trauma
What is being tested?
VHA algorithm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
7 sitesin 5 countries
Study dates
1 Jun 2016to 30 Jul 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Any inclusion criteria are not met

Trial locations and contacts

7 sites in 5 countries.

7 sites in 5 countries

United Kingdom3 sites

  • The Royal London Hospital

    London, Greater London, E1 1BB

  • Queens Medical Centre

    Nottingham

  • John Radcliffe Hospital

    Oxford

Other trials in United Kingdom

Denmark1 site

  • Copenhagen University Hospital

    Copenhagen

Other trials in Denmark

Germany1 site

  • Kliniken der Stadt Köln gGmbH

    Cologne

Other trials in Germany

Netherlands1 site

  • Academic Medical Centre

    Amsterdam

Other trials in Netherlands

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
VHA algorithm
Keywords
Trauma, Hemostasis, Resuscitation, Coagulopathy, Transfusion
Medical subject headings
Hemorrhage, Hemostatic Disorders, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT02593877
Study groupRoleWhat they receive
VHA algorithmExperimentalMassive 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
Receives: Device: VHA algorithm
ControlNo interventionMassive 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24 hours

Secondary outcomes (19)

  1. 6hr Mortality

    All-cause mortality at 6-hours post admission

    Measured: 6 hours

  2. 24hr Mortality

    All-cause mortality at 24-hours post admission

    Measured: 24 hours

  3. 28d Mortality

    All-cause mortality at 28-days post admission

    Measured: 28-days

  4. 90d Mortality

    All-cause mortality at 90-days post admission

    Measured: 90-days

  5. 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).

    Measured: 28-days post admission

  6. 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).

    Measured: 28-days post admission

  7. Proportion of patients with corrected coagulopathy after first 8U RBC

    Proportion of patients with corrected coagulopathy after first 8U RBC

    Measured: 28-days post admission

  8. Time to hemostasis

    Time from Admission to the point of hemostasis (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).

    Measured: 28-days post admission

  9. Time spent in coagulopathic condition until haemostasis

    Time of haemostasis is defined the period from Admission to the point 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. Coagulopathy defined as PTr >1.2.

    Measured: 28-days post admission

  10. 6hr Blood products transfused

    Total blood products (RBC, plasma, platelets alone and in total) transfused in first 6hours after admission

    Measured: 6 hours

  11. 24hr Blood products transfused

    Total blood products (RBC, plasma, platelets alone and in total) transfused in first 24hours after admission

    Measured: 24 hours

  12. 28d Ventilator-free days

    Calculated by the subtracting the number of days spent on mechanical ventilation from 28.

    Measured: 28 days

  13. 28d ICU-free days

    Calculated by the subtracting the number of days spent on intensive care unit from 28.

    Measured: 28 days

  14. Length of stay

    Length of stay will be recorded in days, for the total number spent in ICU and in Hospital. If the patient is in the hospital at any time point during a day, this day will be considered a hospital day.

    Measured: 28 days

  15. Symptomatic thromboembolic events

    Symptomatic venous thromboembolic events shall be recorded, as confirmed by radiology. Other thromboembolic events such as myocardial infarction and/or stroke shall be identified by standard clinical diagnostic investigation(s).

    Measured: 28 days

  16. Transfusion-related complications

    Incidence, category and severity of acute transfusion reactions will be defined according to UK SHOT (United Kingdom Serious Hazards of Transfusion)

    Measured: 28-days

  17. Organ dysfunction

    Organ dysfunction shall be measured as Sequential Organ Failure Assessment (SOFA) score from admission to day 28 or discharge

    Measured: 28-days

  18. 28d/discharge QoL

    Health-Related Quality of Life (HRQoL) will be measured at 28 day post admission or upon discharge if sooner

    Measured: 28 days

  19. 90d QoL

    Health-Related Quality of Life (HRQoL) will be measured at 90 day post admission

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2015 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion3 Jul 2018
  4. Study completion30 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02593877
Sponsor's protocol ID
010770
Acronym
iTACTIC
Status last verified
Aug 2018
First submitted
15 Oct 2015
Last updated
29 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29047413

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VHA algorithm in people with Hemorrhage and Coagulopathy, run by Queen Mary University of London at 7 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom, Denmark, Germany, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects alive and free of massive transfusion (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02593877, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.

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