Monitoring van de stolling bij jonge ECMO patienten

Bleeding and clotting complications occur in about 50% of the pediatric extracorporeal membrane oxygenation (ECMO) patients, causing a decrease in survival of about 40%.(1-3) The interaction between blood and the ECMO circuit generates a hypercoagulable state, and unfractionated heparin is used to maintain patency of the circuit as well as to reduce thrombotic events while minimizing bleedings. Worldwide, no consensus exists about how to monitor this precarious hemostatic balance.

Current conventional tests (APTT, ACT and anti-FXa assay) assess only isolated parts of the coagulation cascade, while alternative tests (thromboelastography [TEG/ROTEM] and thrombin generation assay [TGA]) assess the complete coagulation cascade. Therefore, we hypothese that the alternative coagulation tests better reflect the thrombotic or haemorrhagic phenotype than the conventional tests, and as a consequence will improve coagulation monitoring in ECMO patients, leading to less hemostatic complications and improved survival. In this pilot study we will prospectively investigate the ability of both conventional and alternative coagulation tests to predict bleeding and clotting complications in 160 ECMO children in 8 established ECMO centers worldwide. We expect to find one or a combination of coagulation tests with a good association with the bleeding and/or clotting complications. In a future project, the test(s) can be incorporated in a new anticoagulation protocol, that will be studied in a randomized controlled trial.

Addition of alternative tests (TEG/ROTEM® and/or TGA) which reflect the whole hemostatic status of a patient might help recognizing the level of thrombin formation and fibrinolysis and improve care in ECMO patients and potentially reduce the risk of hemostatic complications.

Before start of ECMO, the first 14 days of ECMO therapy and within 24 hrs after stop of ECMO.

Collecting data about all coagulation tests during the first 14 days of ECMO, including conventional tests such as APTT, PT/INR, ACT, platelets, anti-Xa level, D-dimer, antithrombin and alternative tests, including ROTEM/TEG and TGA.