Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355625
• Other study ID #: ECMO-Camilla
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment with veno-venous or veno-arterial ECMO

• Age =18 years

Exclusion Criteria:

• ECMO treatment initiated post-operatively

Related Conditions & MeSH terms

• Blood Platelets
• Extracorporeal Membrane Oxygenation
• Intensive Care Units
• Platelet Activation
• Platelet Aggregation
• Platelet Function Tests

Locations

Country	Name	City	State
Denmark	Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital	Aarhus
Denmark	Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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)
Secondary	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)