Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim of this study is to provide a detailed analysis of the activity of different coagulation factors and changes in functional coagulation measurements as in rotational thrombelastometry and multiple electrode aggregometry in the course of ECMO therapy.
Study Type
OBSERVATIONAL
Enrollment
20
Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry
University Medical Center Goettingen
Göttingen, Germany
Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy
Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor V [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor X [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
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Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
vWF-Antigen
Measurement of the vWF-Antigen
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy
Repeated assessments of the vWF:Ristocetin-Cofaktor-Activity \[%\]
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in CT-EXTEM
Changes in clotting time (CT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-INTEM
Changes in clotting time (CT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-FIBTEM
Changes in clotting time (CT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-HEPTEM
Changes in clotting time (CT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-EXTEM
Changes in clot formation time (CFT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-INTEM
Changes in clot formation time (CFT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-FIBTEM
Changes in clot formation time (CFT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-HEPTEM
Changes in clot formation time (CFT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-EXTEM
Changes in maximum clot firmness (MCF) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-INTEM
Changes in maximum clot firmness (MCF) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-FIBTEM
Changes in maximum clot firmness (MCF) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in millimeters.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-HEPTEM
Changes in maximum clot firmness (MCF) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in millimeters.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-EXTEM
Changes in Alpha angle in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-INTEM
Changes in Alpha angle in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-FIBTEM
Changes in Alpha angle in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in degree.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-HEPTEM
Changes in Alpha angle in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in degree.
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)
Platelet aggregation after stimulation with arachidonic acid was recorded in aggregational units (AU).
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)
Platelet aggregation after stimulation with ADP was recorded in aggregational units (AU).
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)
Platelet aggregation after stimulation with TRAP was recorded in aggregational units (AU).
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Light transmission aggregometry
Measurement of platelet function
Time frame: 6 hours and 7 days after canulation
Quick
Measurement of Quick in %
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated partial thromboplastin time (aPTT)
Measurement of aPTT in seconds
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Fibrinogen
Measurement of fibrinogen concentration in mg/dl
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Platelet count
Measurement of platelet count/µl
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated clotting time (ACT)
Measurement of ACT in seconds
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Antithrombin III (ATIII)
Measurement of ATIII in %
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of Anti-Xa-Activity in %
Measurement of Anti-Xa-Activity by chromogenic assay to determine heparin effect
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
D-Dimers
Measurement of D-Dimers
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
hemoglobin
hemoglobin concentration in g/dl
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
leucocyte count
leucocyte count/µl
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Hemorrhagic complications
Structured documentation of hemorrhagic complications
Time frame: Daily from day 1-21
Thrombotic complications
Structured documentation of thrombotic complications
Time frame: Daily from day 1-21
Oxygenator State
Structured documentation of the state of the oxygenator including search for thrombotic material
Time frame: Daily from day 1-21