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Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

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ClinicalTrials.gov Identifier: NCT03355625
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )

Brief Summary:

The primary aim is to describe platelet function in adult patients treated with extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these critically ill patients contributes to an understanding of the mechanisms underlying their coagulopathy.

The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).


Condition or disease
Extracorporeal Membrane Oxygenation Platelet Activation Platelet Aggregation Platelet Function Tests Blood Platelets Intensive Care Units

Detailed Description:

The knowledge of platelet function during extracorporeal membrane oxygenation (ECMO) remains sparse. In the present study, the aim is to investigate platelet function in adult patients treated with ECMO using flow cytometry. The investigators hypothesize that platelet function increases from day 1 to day 3 in patients treated with ECMO. The secondary aim is to investigate the association between platelet function and the incidence of bleeding episodes and thrombosis during ECMO treatment.

The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).

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Study Type : Observational
Estimated Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019



Primary Outcome Measures :
  1. Changes in platelet function [ Time Frame: Platelet function measured day 1 and day 3 on ECMO ]
    Platelet function on day 3 compared with day 1 on ECMO. Measured by flow cytometry


Secondary Outcome Measures :
  1. Changes in platelet aggregation [ Time Frame: Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends). ]
    Comparison of platelet aggregation measured by whole blood impedance aggregometry (Multiplate).

  2. Immature platelet count [ Time Frame: Measured every morning from day 1 to day 8 on ECMO (except weekends) ]
    Estimation of platelet turn-over measured by a blood analyzer (Sysmex)

  3. Platelet count [ Time Frame: Measured every morning from day 1 to day 8 on ECMO (except weekends) ]
    Estimation of platelet count measured by a blood analyzer (Sysmex)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated with ECMO at the Intensive Care Unit East, Aarhus University Hospital.
Criteria

Inclusion Criteria:

  • Treatment with veno-venous or veno-arterial ECMO
  • Age ≥18 years

Exclusion Criteria:

  • ECMO treatment initiated post-operatively

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355625


Contacts
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Contact: Camilla Mains Balle, Research fellow +45 40769623 camillaballe@gmail.com
Contact: Anni Nørgaard Jeppesen, MD, PhD +45 30910927 anni.jeppesen@clin.au.dk

Locations
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Denmark
Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
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Principal Investigator: Camilla Mains Balle, Research fellow Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Study Chair: Anne-Mette Hvas, Professor, MD, PhD Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Study Chair: Anni Nørgaard Jeppesen, MD, PhD Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
Study Chair: Steffen Christensen, MD, PhD Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
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Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03355625    
Other Study ID Numbers: ECMO-Camilla
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus ( Aarhus University Hospital ):
Flow Cytometry
eCPR
Extracorporeal Life Support