Coagulation Factor Deficiency, Extracorporeal Membrane Oxygenation Complication
Conditions
Keywords
ECMO, Coagulation monitoring, point-of-care
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.
Interventions
DIAGNOSTIC_TESTDetailed coagulation monitoring
Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry
Sponsors
University Hospital Goettingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Need for a Veno-venous extracorporeal membrane oxygenation therapy
Exclusion criteria
* Known coagulation disorders * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| activated clotting time (ACT) | Pre-canulation, 6 hours and daily from day 1- day 21after canulation | Measurement of ACT in seconds |
| 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 \[%\] |
| 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 |
| 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. |
Countries
Germany
Outcome results
None listed