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Completed

NCT Number: NCT03754868

Evaluation of Coagulation Factors and Point-of-care Devices During 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.

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Key information

Conditions

Extracorporeal Membrane Oxygenation Complication Coagulation Factor Deficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Goettingen

Göttingen, 37075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Need for a Veno-venous extracorporeal membrane oxygenation therapy

Exclusion criteria

  • Known coagulation disorders
  • Refusal to participate

Treatment and study plan

Detailed coagulation monitoring

Diagnostic Test

Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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

  2. 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 [%]

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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).

  20. 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).

  21. 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).

  22. Light transmission aggregometry

    Time frame: 6 hours and 7 days after canulation

    Measurement of platelet function

  23. Quick

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    Measurement of Quick in %

  24. activated partial thromboplastin time (aPTT)

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    Measurement of aPTT in seconds

  25. Fibrinogen

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    Measurement of fibrinogen concentration in mg/dl

  26. Platelet count

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    Measurement of platelet count/µl

  27. activated clotting time (ACT)

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    Measurement of ACT in seconds

  28. Antithrombin III (ATIII)

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    Measurement of ATIII in %

  29. 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

  30. 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

  31. hemoglobin

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    hemoglobin concentration in g/dl

  32. leucocyte count

    Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation

    leucocyte count/µl

  33. Hemorrhagic complications

    Time frame: Daily from day 1-21

    Structured documentation of hemorrhagic complications

  34. Thrombotic complications

    Time frame: Daily from day 1-21

    Structured documentation of thrombotic complications

  35. Oxygenator State

    Time frame: Daily from day 1-21

    Structured documentation of the state of the oxygenator including search for thrombotic material

Sponsors and collaborators

Lead sponsor

University Hospital Goettingen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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