Comparison of the Point-of-care Coagulation Device Quantra With the TEG for Congenital Cardiac Surgery - a Pilot Validation Study

Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB. Therefore, coagulation products and blood products often need to be given/transfused during these cases. The correct choice and dosing of coagulation products is essential to effectively stop bleeding and reduce the need of additional blood transfusion.

The current testing device used at our institution during congenital heart surgery on CPB is the TEG 5000 (Haemonetics Corporation). Prior to separation from CPB (mostly 30-60 minutes) and after the first coagulation products were given (approx. 60 minutes after separation from CPB) a Clauss Fibrinogen and a TEG are drawn. These samples are sent to an off-site lab for processing and time to result ranges from 60-90 minutes. Therefore, results are often not present when needed.

An easy to use point-of-care (POC) test device being readily available in the operation room and allowing for rapid results could result in quicker identification of the coagulation problem and hence allow for faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products.

The Quantra System (Hemosonics) is an easy-to-use, stand-alone device presenting results within 20 minutes. With these properties all above mentioned problems would be addressed. To date the Quantra has not been used and has not been evaluated in patients with congenital heart disease for cardiac surgery on CPB.

The aim of this prospective observational (non-interventional, investigational only) quality improvement study is to investigate if the Quantra is reliable and valid in predicting the coagulation status when compared with our standard-of-care device TEG