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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detailed coagulation monitoring | Diagnostic Test | Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| vWF-Antigen | Measurement of the vWF-Antigen | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care unit.
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| Name | Affiliation | Role |
|---|---|---|
| Onnen Moerer, Prof. | Department of Anesthesiology, University Medical Center Goettingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Goettingen | Göttingen | 37075 | Germany |
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Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.
| 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 XII [%] during Veno-venous ECMO | Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods. | 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. | Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation |
Repeated assessments of the vWF:Ristocetin-Cofaktor-Activity [%]
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation |
| Light transmission aggregometry | Measurement of platelet function | 6 hours and 7 days after canulation |
| Quick | Measurement of Quick in % | Pre-canulation, 6 hours and daily from day 1- day 21after canulation |
| activated partial thromboplastin time (aPTT) | Measurement of aPTT in seconds | Pre-canulation, 6 hours and daily from day 1- day 21after canulation |
| Fibrinogen | Measurement of fibrinogen concentration in mg/dl | Pre-canulation, 6 hours and daily from day 1- day 21after canulation |
| Platelet count | Measurement of platelet count/µl | Pre-canulation, 6 hours and daily from day 1- day 21after canulation |
| activated clotting time (ACT) | Measurement of ACT in seconds | Pre-canulation, 6 hours and daily from day 1- day 21after canulation |
| Antithrombin III (ATIII) | Measurement of ATIII in % | 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 | 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 | 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 | Pre-canulation, 6 hours and daily from day 1- day 21after canulation |
| leucocyte count | leucocyte count/µl | Pre-canulation, 6 hours and daily from day 1- day 21after canulation |
| Hemorrhagic complications | Structured documentation of hemorrhagic complications | Daily from day 1-21 |
| Thrombotic complications | Structured documentation of thrombotic complications | Daily from day 1-21 |
| Oxygenator State | Structured documentation of the state of the oxygenator including search for thrombotic material | Daily from day 1-21 |