VHA no better than CCT in guiding haemostatic therapy for trauma
Adding Viscoelastic Haemostatic Assay (VHA) to empiric standard major haemorrhage protocol (MHP) in management of trauma did not improve overall outcomes compared with conventional coagulation test (CCT)-guided interventions, according to the ITACTIC* study presented at eCCR 2021.
“Contemporary trauma resuscitation prioritizes control of bleeding and uses MHPs [involving timely administration of haemostatic therapy] to prevent and treat coagulopathy,” said the researchers.
“However, it is known that these strategies are rarely able to fully correct coagulopathy once established, and all patients receive the same management approach, regardless of the severity or nature of their haemostatic deficits,” they explained.
Alternative individualized approaches that aim to detect and correct coagulopathy may help augment empiric haemostatic resuscitation in trauma care. VHA and CCT are two such intensive coagulation monitoring strategies to guide haemostatic therapies in MHP.
The pragmatic multicentre ITACTIC trial randomized 396 trauma patients in a 1:1 ratio to either receive VHA- or CCT-guided interventions, in augmenting empiric standard MHPs. [Intensive Care Med 2021;47:49-59]
At 24 hours after injury, the primary outcome of survival rate free of massive transfusion was similar in both the VHA- and CCT-guided arms (67 percent vs 64 percent; odds ratio [OR], 1.15, 95 percent confidence interval [CI], 0.76–1.73).
Similarly, no significant differences were found in the primary outcome in per-protocol analysis as well as across prespecified subgroups, regardless of prior use of oral anticoagulants and presence of baseline PTr** of >1.2.
The secondary outcome of 28-day mortality was also comparable between the two groups overall (25 percent vs 28 percent; OR, 0.84, 95 percent CI, 0.54–1.31).
Likewise, there were no significant differences between the two groups in other secondary outcomes, including the rates of symptomatic thromboembolic events, multiple organ dysfunction, and ICU-free days or ventilator-free days at day 28.
“For those patients who never developed a coagulopathy, it is unsurprising that coagulation monitoring did not alter the clinical outcome,” the researchers pointed out. As coagulopathy was less prevalent than expected in the study, this limits the “ability to detect a difference in clinical outcomes.”
Hints of potential benefits
“Despite the delivery of optimized and individualized standard of care in both cohorts, 67 percent of patients in the VHA-augmented cohort received study interventions, 1.8 times more than in the CCT group,” noted the researcher. “This indicates the widespread occurrence of coagulation deficits which were not detected by the CCTs.”
When restricting the analysis to a prespecified subgroup of patients with severe traumatic brain injury (TBI; n=74), the rate of survival free of massive transfusion at 24 hours in the VHA-guided arm was double that in the CCT-guided arm (64 percent vs 46 percent; OR, 2.12, 95 percent CI, 0.84–5.34).
Furthermore, the risk of 28-day mortality was reduced by 72 percent in patients with TBI who received VHA-guided interventions compared with those under CCT-guided interventions (OR, 0.28, 95 percent CI, 0.10–0.74).
“TBI is responsible for at least 25 percent of deaths in critically bleeding patients, and 50 percent of all trauma deaths,” said the researchers. “[If these findings are validated] in future work, [VHA-guided intervention] potentially represents an important opportunity for improving outcomes in trauma care.”
“[Although overall] patients do not benefit from this approach, further research is required to identify injury types and physiologies that may benefit from this approach,” they added.
*ITACTIC: Implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy
**PTr: Prothrombin time ratio