Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.
- Changes in the activity of coagulation factor V [%] during Veno-venous ECMO [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.
- Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.
- Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.
- Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.
- Changes in the activity of coagulation factor X [%] during Veno-venous ECMO [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.
- Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.
- Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.
Secondary Outcome Measures
- vWF-Antigen [Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation]
Measurement of the vWF-Antigen
- Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy [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 [%]
- Changes in CT-EXTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in clotting time (CT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
- Changes in CT-INTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in clotting time (CT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
- Changes in CT-FIBTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in CT-HEPTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in CFT-EXTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in clot formation time (CFT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
- Changes in CFT-INTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in clot formation time (CFT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
- Changes in CFT-FIBTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in CFT-HEPTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in MCF-EXTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in maximum clot firmness (MCF) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
- Changes in MCF-INTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in maximum clot firmness (MCF) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
- Changes in MCF-FIBTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in MCF-HEPTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in Alpha angle-EXTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in Alpha angle in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
- Changes in Alpha angle-INTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Changes in Alpha angle in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
- Changes in Alpha angle-FIBTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in Alpha angle-HEPTEM [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
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.
- Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest) [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Platelet aggregation after stimulation with arachidonic acid was recorded in aggregational units (AU).
- Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest) [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Platelet aggregation after stimulation with ADP was recorded in aggregational units (AU).
- Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest) [Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation]
Platelet aggregation after stimulation with TRAP was recorded in aggregational units (AU).
- Light transmission aggregometry [6 hours and 7 days after canulation]
Measurement of platelet function
- Quick [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
Measurement of Quick in %
- activated partial thromboplastin time (aPTT) [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
Measurement of aPTT in seconds
- Fibrinogen [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
Measurement of fibrinogen concentration in mg/dl
- Platelet count [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
Measurement of platelet count/µl
- activated clotting time (ACT) [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
Measurement of ACT in seconds
- Antithrombin III (ATIII) [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
Measurement of ATIII in %
- Measurement of Anti-Xa-Activity in % [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]
Measurement of Anti-Xa-Activity by chromogenic assay to determine heparin effect
- 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]
Measurement of D-Dimers
- hemoglobin [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
hemoglobin concentration in g/dl
- leucocyte count [Pre-canulation, 6 hours and daily from day 1- day 21after canulation]
leucocyte count/µl
- Hemorrhagic complications [Daily from day 1-21]
Structured documentation of hemorrhagic complications
- Thrombotic complications [Daily from day 1-21]
Structured documentation of thrombotic complications
- Oxygenator State [Daily from day 1-21]
Structured documentation of the state of the oxygenator including search for thrombotic material
Eligibility Criteria
Criteria
Inclusion Criteria:
- Need for a Veno-venous extracorporeal membrane oxygenation therapy
Exclusion Criteria:
-
Known coagulation disorders
-
Refusal to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Goettingen | Goettingen | Germany | 37075 |
Sponsors and Collaborators
- University Hospital Goettingen
Investigators
- Principal Investigator: Onnen Moerer, Prof., Department of Anesthesiology, University Medical Center Goettingen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19/5/13