Clinical trial NCT03355625: Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
Official title: Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation
Platelet Activation
Platelet Aggregation
Platelet Function Tests
Blood Platelets
Intensive Care Units
Keywords: Flow Cytometry
eCPR
Extracorporeal Life Support
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2017-11-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with ECMO at the Intensive Care Unit East, 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).

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ECMO treatment initiated post-operatively

Primary outcomes:
measure: Changes in platelet function
timeFrame: Platelet function measured day 1 and day 3 on ECMO
Secondary outcomes:
measure: Changes in platelet aggregation
timeFrame: Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends).
measure: Immature platelet count
timeFrame: Measured every morning from day 1 to day 8 on ECMO (except weekends)
measure: Platelet count
timeFrame: Measured every morning from day 1 to day 8 on ECMO (except weekends)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
Study officials:
affiliation: Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
name: Camilla Mains Balle, Research fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
name: Anne-Mette Hvas, Professor, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
name: Anni Nørgaard Jeppesen, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
name: Steffen Christensen, MD, PhD
role: STUDY_CHAIR
References: