NCT02593877: iTACTIC

Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy

Completed Phase 2 Last updated 29 August 2018

What this trial tests

Phase 2 trial testing VHA algorithm in Hemorrhage in 412 participants. Completed in 30 July 2018.

Timeline

1 June 2016

Primary endpoint
3 July 2018

30 July 2018

Quick facts

Lead sponsor	Queen Mary University of London
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	412
Start date	1 June 2016
Primary completion	3 July 2018
Estimated completion	30 July 2018
Sites	7 locations across Denmark, Netherlands, United Kingdom, Germany, Norway

Drugs / interventions tested

• VHA algorithm

Conditions studied

• Hemorrhage — all drugs for Hemorrhage →
• Coagulopathy — all drugs for Coagulopathy →
• Trauma — all drugs for Trauma →

Sponsor

Queen Mary University of London

Who can join

16 and older, any sex, with Hemorrhage or Coagulopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition.
   Rossaint R, Afshari A, Bouillon B, Cerny V, et al · · 2023 · cited 406× · PMID 36859355 · DOI 10.1186/s13054-023-04327-7
2. Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial.
   Baksaas-Aasen K, Gall LS, Stensballe J, Juffermans NP, et al · · 2021 · cited 206× · PMID 33048195 · DOI 10.1007/s00134-020-06266-1
3. Thromboelastography (TEG) or thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding.
   Wikkelsø A, Wetterslev J, Møller AM, Afshari A. · · 2016 · cited 184× · PMID 27552162 · DOI 10.1002/14651858.cd007871.pub3
4. The role of evidence-based algorithms for rotational thromboelastometry-guided bleeding management.
   Görlinger K, Pérez-Ferrer A, Dirkmann D, Saner F, et al · · 2019 · cited 138× · PMID 31096732 · DOI 10.4097/kja.19169
5. Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial.
   Curry N, Foley C, Wong H, Mora A, et al · · 2018 · cited 76× · PMID 29914530 · DOI 10.1186/s13054-018-2086-x
6. The use of viscoelastic haemostatic assays in goal-directing treatment with allogeneic blood products - A systematic review and meta-analysis.
   Fahrendorff M, Oliveri RS, Johansson PI. · · 2017 · cited 62× · PMID 28403868 · DOI 10.1186/s13049-017-0378-9
7. Rotational thromboelastometry significantly optimizes transfusion practices for damage control resuscitation in combat casualties.
   Prat NJ, Meyer AD, Ingalls NK, Trichereau J, et al · · 2017 · cited 41× · PMID 28846577 · DOI 10.1097/ta.0000000000001568
8. iTACTIC - implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a multicentre, randomised controlled trial.
   Baksaas-Aasen K, Gall L, Eaglestone S, Rourke C, et al · · 2017 · cited 40× · PMID 29047413 · DOI 10.1186/s13063-017-2224-9