Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

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).

Study Overview

• Status: Completed
• Conditions: Extracorporeal Membrane Oxygenation; Platelet Aggregation; Platelet Activation; Intensive Care Units; Blood Platelets; Platelet Function Tests

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).

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
  • Aarhus, Denmark, 8000
    • Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated with ECMO at the Intensive Care Unit East, Aarhus University Hospital.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• ECMO treatment initiated post-operatively

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in platelet function	Platelet function on day 3 compared with day 1 on ECMO. Measured by flow cytometry	Platelet function measured day 1 and day 3 on ECMO

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in platelet aggregation	Comparison of platelet aggregation measured by whole blood impedance aggregometry (Multiplate).	Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends).
Immature platelet count	Estimation of platelet turn-over measured by a blood analyzer (Sysmex)	Measured every morning from day 1 to day 8 on ECMO (except weekends)
Platelet count	Estimation of platelet count measured by a blood analyzer (Sysmex)	Measured every morning from day 1 to day 8 on ECMO (except weekends)

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: University of Aarhus
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Extracorporeal Life Support; Flow Cytometry; eCPR
• Other Study ID Numbers: ECMO-Camilla

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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