Extracorporeal Membrane Oxygenation Complication Clinical Trial
Official title:
Prospective Randomized Study Of Anticoagulation Monitoring With Thromboelastography Versus aPTT During Extracorporeal Membrane Oxygenation In Adults
The best anticoagulation strategy during Extracorporeal Membrane Oxygenation (ECMO) is unknown. Actual recommendations suggest to use unfractionated heparin infusion and monitor the effect with either activated Partial Thromboplastin Time (aPTT) or Activated Clotting Time (ACT). Since hemorrhage is still the major adverse effect of ECMO with impact on mortality and morbidity, the investigators raised a question whether an alternative monitoring technique namely Thromboelastography (TEG) could allow a more accurate management of anticoagulation in this setting. To test this hypothesis the investigators designed a pilot study to test safety and feasibility of an anticoagulation monitoring algorithm based on TEG versus aPTT.
Extracorporeal membrane oxygenation (ECMO) is frequently used as a supportive tool in the
settings of acute severe respiratory and/or circulatory failure. The presence of the
extracorporeal circuit and oxygenator bring along the need to anticoagulate the patients in
order to prevent activation of the coagulation cascade that can lead to thrombosis of the
artificial surfaces and losses of coagulation factors, fibrinogen and platelets. Despite
tight monitoring with different anticoagulation essays bleeding remain the main threat for
the patients on ECMO, leaving thrombosis as an anecdotic event.
In our institution, anticoagulation during ECMO is monitored mainly with aPTT ratio in a
range of 1.5 to 2 (patient to normal). Recently, the investigators started to match
Thromboelastography (TEG) assays to activated Partial Thromboplastin Time (aPTT) and
Activated Clotting Time (ACT) routine measurements during ECMO. Data from a preliminary
analysis of thirty-two patients show that in nearly half of TEG assays, the R (reaction time)
parameter which is sensitive to inhibition of fibrin formation by heparin, was consistently
prolonged despite aPTT and ACT were in the normal range. In the same patients the
investigators registered high rate of bleeding (nearly 40% of patients suffered from
clinically significant bleeding, i.e. bleeding that required heparin dose reduction, blood
transfusions or interruption of the extracorporeal support). These findings suggests the
possibility that the actual target of aPTT ratio might be overrated.
The purpose of this study is to test safety and feasibility of standardized protocol based on
TEG versus current practice (aPTT) to manage anticoagulation during ECMO.
40 consecutive adults patients undergoing ECMO will be randomized in either the TEG-driven
anticoagulation group or the aPTT-driven group. Written informed consent will be obtained
according to national legislation.
In both groups, when the patient is connected to ECMO, an heparin bolus of 50-70 UI/kg
(depending on baseline aPTT value) will be administered followed by a continuous infusion of
18 UI/kg/h started; for the first 12 hours thereafter proper anticoagulation level will be
monitored with Activated Clotting Time (ACT, therapeutic range 180-210 seconds, performed
every 1 or 2 hours according to the standardized protocol). From the thirteenth hour onwards
each group will follow either aPTT monitoring or TEG according to randomization. Every
morning in both groups aPTT, TEG, Antithrombin and anti-Factor Xa activity will be assessed.
- aPTT-driven group: aPTT ratio target is 1.5 - 2.0 as for actual clinical practice;
frequency of aPTT measurements may vary from a minimum of 3 times per day to a maximum
of 6 depending on the standardized protocol. When aPTT value falls well below the
desired range an heparin bolus will be administered. When too high, infusion will be
stopped for either 30 or 60 minutes.
- TEG-driven group: target range of R parameter at Kaolin activated-TEG (R K-TEG) is 16 -
24 minutes; frequency of TEG assays may vary from a minimum of 3 times per day to a
maximum of 6 depending on the standardized protocol. When TEG value falls well below the
desired range an heparin bolus will be administered, when is too high infusion will be
stopped for either 30 or 60 minutes.
Daily management requires haemoglobin, platelets, PT ratio, D-dimer and fibrinogen to be
checked 2 to 3 times daily, and maintained at specific values (Hb > 10 g/dl; PLT >
45.000/mm3; Fibrinogen > 150 mg/dl; Antithrombin activity > 70%; PT ratio > 1.5) with
haemocomponents transfusion.
Data from each patient will be collected on a daily basis: laboratory exams, hemodynamic
status, transfusions, surgery or invasive interventions, extracorporeal lung performance.
End of the study will be at ECMO discontinuation, after that deep vein thrombosis on
patients' cannulation sites will be assessed with doppler ultrasound.
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