Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

Analysis of the Activity of Different Coagulation Factors and Monitoring of Coagulation Using Point-of-care Devices During a Veno-venous ECMO Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754868
• Other study ID #: 19/5/13
• Status: Completed
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2018
• Source: University Hospital Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Need for a Veno-venous extracorporeal membrane oxygenation therapy

Exclusion Criteria:

• Known coagulation disorders

• Refusal to participate

Related Conditions & MeSH terms

• Coagulation Factor Deficiency
• Extracorporeal Membrane Oxygenation Complication

Intervention

Diagnostic Test:
• Detailed coagulation monitoring
Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry

Locations

Country	Name	City	State
Germany	University Medical Center Goettingen	Goettingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Primary	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
Primary	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
Secondary	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
Secondary	Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Light transmission aggregometry	Measurement of platelet function	6 hours and 7 days after canulation
Secondary	Quick	Measurement of Quick in %	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	activated partial thromboplastin time (aPTT)	Measurement of aPTT in seconds	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	Fibrinogen	Measurement of fibrinogen concentration in mg/dl	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	Platelet count	Measurement of platelet count/µl	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	activated clotting time (ACT)	Measurement of ACT in seconds	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	Antithrombin III (ATIII)	Measurement of ATIII in %	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	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
Secondary	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
Secondary	hemoglobin	hemoglobin concentration in g/dl	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	leucocyte count	leucocyte count/µl	Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Secondary	Hemorrhagic complications	Structured documentation of hemorrhagic complications	Daily from day 1-21
Secondary	Thrombotic complications	Structured documentation of thrombotic complications	Daily from day 1-21
Secondary	Oxygenator State	Structured documentation of the state of the oxygenator including search for thrombotic material	Daily from day 1-21