Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial

Abstract

Purpose: Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We aimed to determine whether augmenting MHPs with Viscoelastic Haemostatic Assays (VHA) would improve outcomes compared to Conventional Coagulation Tests (CCTs). Methods: This was a multi-centre, randomized controlled trial comparing outcomes in trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions. Primary outcome was the proportion of subjects who, at 24 h after injury, were alive and free of massive transfusion (10 or more red cell transfusions). Secondary outcomes included 28-day mortality. Pre-specified subgroups included patients with severe traumatic brain injury (TBI). Results: Of 396 patients in the intention to treat analysis, 201 were allocated to VHA and 195 to CCT-guided therapy. At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA: 67%, CCT: 64%, OR 1.15, 95% CI 0.76-1.73). 28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified subgroups, there were no differences in primary outcomes. In the pre-specified subgroup of 74 patients with TBI, 64% were alive and free of massive transfusion at 24 h compared to 46% in the CCT arm (OR 2.12, 95% CI 0.84-5.34). Conclusion: There was no difference in overall outcomes between VHA-and CCT-augmented-major haemorrhage protocols.

Whole Blood, Fixed Ratio, or Goal-Directed Blood Component Therapy for the Initial Resuscitation of Severely Hemorrhaging Trauma Patients: A Narrative Review

“…This trial demonstrated no statistical evidence that the use of VETs versus standard therapy guided by standard coagulation tests improved 28 day mortality. However, similar confounding factors were also found with the PROPPR trial [ 99 ]. Despite the high injury severity scores, a relatively small percentage of either group received MT within 24 h. This is also reflected by the low incidence of TIC in both groups.…”

“…Additionally, the authors of the trial do not comment on the percentage of centers which used either ROTEM or TEG devices to guide BCT. They state: “The [VET] used at each study site was determined by existing familiarity with a specific device appliance and to ensure a balanced use of the devices across the study” [ 99 ]. This is of importance due to the heterogeneity of thresholds for administering BCT [ 100 , 101 ].…”

“…Finally, a problem consistent with many studies regarding the treatment and diagnosis of patients with severe bleeding and trauma is the definition of MT as 10 units PRBCs in 24 h. This may explain the low incidence of TIC in the iTACTIC study considering that the most effective time for intervention to reverse the pathophysiology of TIC is the first few hours after injury. Only 28% in the standard coagulation tests group and 26% in the VET group had received MT at 24 h [ 99 ]. This traditional MT definition restricts the potential study sample to a less acute group of patients, excludes patients who die early, and excludes those who may have benefitted from early use of VET-guided resuscitation [ 102 ].…”

“…This traditional MT definition restricts the potential study sample to a less acute group of patients, excludes patients who die early, and excludes those who may have benefitted from early use of VET-guided resuscitation [ 102 ]. These issues indicate that the population studied may not have been sick enough to benefit from VET-guided trauma resuscitation [ 99 ]. More recent data suggest that >4 units PRBCs in the first hour is a more meaningful definition of MT [ 103 ].…”

“… Abbreviations: AABB, American Association of Blood Banks; BCT, blood component therapy; RCT, randomized control trial; VET, viscoelastic test [ 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 14 , 40 , 42 , 46 , 47 , 52 , 54 , 59 , 61 , 69 , 78 , 85 , 86 , 87 , 89 , 94 , 95 , 98 , 99 , 100 , 109 , 115 , 126 ]. …”