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

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

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.

Study Overview

• Status: Completed
• Conditions: Extracorporeal Membrane Oxygenation Complication; Coagulation Factor Deficiency
• Intervention / Treatment: Diagnostic test: Detailed coagulation monitoring

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Germany
  • Goettingen, Germany, 37075
    • University Medical Center Goettingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care unit.

Description

Inclusion Criteria:

• Need for a Veno-venous extracorporeal membrane oxygenation therapy

Exclusion Criteria:

• Known coagulation disorders
• Refusal to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital Goettingen
• Investigators: Principal Investigator: Onnen Moerer, Prof., Department of Anesthesiology, University Medical Center Goettingen

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (ACTUAL): November 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: ECMO; point-of-care; Coagulation monitoring
• Other Study ID Numbers: 19/5/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No