Clinical trial NCT03754868: Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation Complication
Coagulation Factor Deficiency
Keywords: ECMO
Coagulation monitoring
point-of-care
Lead sponsor: University Hospital Goettingen
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care unit.

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.


Eligibility criteria: Inclusion Criteria:

* Need for a Veno-venous extracorporeal membrane oxygenation therapy

Exclusion Criteria:

* Known coagulation disorders
* Refusal to participate

Primary outcomes:
measure: Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the activity of coagulation factor V [%] during Veno-venous ECMO
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the activity of coagulation factor X [%] during Veno-venous ECMO
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Secondary outcomes:
measure: vWF-Antigen
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy
timeFrame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
measure: Changes in CT-EXTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in CT-INTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in CT-FIBTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in CT-HEPTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in CFT-EXTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in CFT-INTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in CFT-FIBTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in CFT-HEPTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in MCF-EXTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in MCF-INTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in MCF-FIBTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in MCF-HEPTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in Alpha angle-EXTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in Alpha angle-INTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in Alpha angle-FIBTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in Alpha angle-HEPTEM
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)
timeFrame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
measure: Light transmission aggregometry
timeFrame: 6 hours and 7 days after canulation
measure: Quick
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: activated partial thromboplastin time (aPTT)
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: Fibrinogen
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: Platelet count
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: activated clotting time (ACT)
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: Antithrombin III (ATIII)
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: Measurement of Anti-Xa-Activity in %
timeFrame: 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
measure: D-Dimers
timeFrame: 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
measure: hemoglobin
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: leucocyte count
timeFrame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
measure: Hemorrhagic complications
timeFrame: Daily from day 1-21
measure: Thrombotic complications
timeFrame: Daily from day 1-21
measure: Oxygenator State
timeFrame: Daily from day 1-21
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: University Medical Center Goettingen
Study officials:
affiliation: Department of Anesthesiology, University Medical Center Goettingen
name: Onnen Moerer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: