Coronary Artery Disease Clinical Trial
Official title:
Evaluation of the Feasibility of Rotational Thromboelastrometry During Cardiopulmonary Bypass Using a Heparinase Modified ROTEM® Assay
Coagulopathy with transfusion requirements is frequent during cardiac surgery with
cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole
blood point of care test used to assess the patient's coagulation status.
The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence
of very high heparin concentrations as seen during cardiopulmonary bypass.
The Society of Cardiothoracic surgeons suggest that 50% of patients undergoing cardiac
surgery have a blood transfusion.
Several studies indicate an increase in morbidity and mortality related to blood
transfusions.
Traditionally, the coagulation tests are performed in the hematology laboratory.
Rotational thromboelastrometry is a useful method of assessing perioperative coagulation
function in patients undergoing cardiac surgery.
The presence of significant amounts of heparin in blood samples during cardiopulmonary
bypass induces artifactual errors when thromboplastin is used as a reagent. For this reason,
whole blood coagulation monitoring with ROTEM® has not been feasible during cardiopulmonary
bypass with heparin anticoagulation. Recently recombinant thromboplastin has come available.
It's stability is guaranteed by the manufacturer for plasmatic heparin concentrations up to
5UI/l .
Three of the available ROTEM®-tests are EXTEM (activation by recombinant thromboplastin),
INTEM (activation by elagic acid) and HEPTEM. In the latter, heparinase, added to the INTEM
reagent, eliminates heparin to reveal underlying coagulopathies.
The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence
of very high concentration of heparin and to evaluate whether heparinase could reverse
heparin's effect on EXTEM and INTEM during cardiopulmonary bypass.
Arterial blood samples were drawn for analysis after induction of anesthesia (T0),10 minutes
after the administration of heparin (T1), at unclamping of the aorta (T2) and after heparin
reversal with protamine (T3). The following tests will be performed: EXTEM, INTEM, HEPTEM
and a heparinase modified EXTEM. For the latter, recombinant thromboplatin instead of the
elagic acid is used in the HEPTEM test. Heparin concentrations are measured at T1 and at the
end of bypass (T2). HEPCON® was used for heparin management.
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