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

November 22, 2018 updated by: Saskia Wand, University Hospital Goettingen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
vWF-Antigen
Time Frame: 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
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
Time Frame: 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 [%]
Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in CT-EXTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-INTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-FIBTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-HEPTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-EXTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-INTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-FIBTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-HEPTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-EXTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-INTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-FIBTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-HEPTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-EXTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-INTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-FIBTEM
Time Frame: 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.
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-HEPTEM
Time Frame: 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.
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Light transmission aggregometry
Time Frame: 6 hours and 7 days after canulation
Measurement of platelet function
6 hours and 7 days after canulation
Quick
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of Quick in %
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated partial thromboplastin time (aPTT)
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of aPTT in seconds
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Fibrinogen
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of fibrinogen concentration in mg/dl
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Platelet count
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of platelet count/µl
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated clotting time (ACT)
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of ACT in seconds
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Antithrombin III (ATIII)
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of ATIII in %
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of Anti-Xa-Activity in %
Time Frame: 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
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
Time Frame: 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
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
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
hemoglobin concentration in g/dl
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
leucocyte count
Time Frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
leucocyte count/µl
Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Hemorrhagic complications
Time Frame: Daily from day 1-21
Structured documentation of hemorrhagic complications
Daily from day 1-21
Thrombotic complications
Time Frame: Daily from day 1-21
Structured documentation of thrombotic complications
Daily from day 1-21
Oxygenator State
Time Frame: Daily from day 1-21
Structured documentation of the state of the oxygenator including search for thrombotic material
Daily from day 1-21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Goettingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Onnen Moerer, Prof., Department of Anesthesiology, University Medical Center Goettingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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