Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy (iTACTIC)

Queen Mary University of London

Status and phase: Completed; Phase 2

Conditions: Coagulopathy; Hemorrhage; Trauma

Treatments: Device: VHA algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT02593877

010770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 412 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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412 participants in 2 patient groups

VHA algorithm

Experimental group

Description:

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

Treatment:

Device: VHA algorithm

Control

No Intervention group

Description:

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