Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy
- Conditions
- Extracorporeal Membrane Oxygenation ComplicationCoagulation Factor Deficiency
- Registration Number
- NCT03754868
- Lead Sponsor
- University Hospital Goettingen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Need for a Veno-venous extracorporeal membrane oxygenation therapy
- Known coagulation disorders
- Refusal to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method 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.
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 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-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 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-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-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 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 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 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).
Quick Pre-canulation, 6 hours and daily from day 1- day 21after canulation Measurement of Quick in %
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-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 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
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 %
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
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
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
Trial Locations
- Locations (1)
University Medical Center Goettingen
🇩🇪Goettingen, Germany