Comparison of the Point-Of-Care Coagulation Device Quantra With the TEG-5000 for Congenital Cardiac Surgery-A Pilot Study.

BACKGROUND

Congenital cardiac surgery with cardiopulmonary bypass (CPB) alters patients' hemostasis. Viscoelastic testing is a modern technology identifying coagulation abnormalities. A new device, the Quantra-QPlus System (HemoSonics LLC, Charlottesville, VA) has not yet been investigated during congenital cardiac surgery.

AIM: This prospective observational pilot study investigated the correlation of Quantra and TEG-5000 in children undergoing cardiac surgery at Stanford Medicine Children's Health (SMCH).

METHODS

Patients (0-8 years) undergoing cardiac surgery with CPB were included after parental consent. Per standard of care at SMCH, a TEG-5000 and Clauss Fibrinogen were measured on CPB during rewarming (T1) as well as after administration of blood components and coagulation factors (T2). For the study purpose, Quantra measurements were performed simultaneously at T1 and T2. Quantra results were correlated with TEG-5000 results and Clauss Fibrinogen. In addition, the agreement for normal and abnormal results was calculated, and a post hoc simulated transfusion algorithm using TEG-5000 and Quantra thresholds was compared to patients' clinical management.

RESULTS

From October 2022 to May 2023, 289 congenital cardiac surgeries were performed, 97 met inclusion criteria, 63 patients were consented, and 40 patients (12 females [30%] 28 males [70%]) included in the analysis. Median age and weight were 0.5 years and 6.33 kg, respectively. Correlation of Quantra/Clauss Fibrinogen was "moderate" and correlation of Quantra/TEG-5000 parameters ranged from "weak" to "very strong" Levels of agreement ranged from 15% to 97%. The post hoc simulated transfusion algorithm for TEG-5000 showed an agreement of 56% for FFP, 56% for Fibrinogen, and 95% for platelets and for Quantra, it was 40% for FFP, 87.5% for Fibrinogen, and 98% for platelets.

CONCLUSIONS

Despite weaknesses in correlation and agreement both VET devices suggested appropriate coagulation management based on the simulated transfusion algorithms. Quantra and TEG-5000 are not interchangeable and none of them can be considered as "the gold standard".

TRIAL REGISTRATION: NTC 05295693.