NCT03355625

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

November 22, 2017

Last Update Submit

May 25, 2022

Conditions

Keywords

Flow CytometryeCPRExtracorporeal Life Support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in platelet aggregation

    Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends).

  • Immature platelet count

    Measured every morning from day 1 to day 8 on ECMO (except weekends)

  • Platelet count

    Measured every morning from day 1 to day 8 on ECMO (except weekends)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • ECMO treatment initiated post-operatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Study Officials

  • Camilla Mains Balle, Research fellow

    Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 28, 2017

Study Start

September 1, 2017

Primary Completion

September 30, 2019

Study Completion

November 30, 2019

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations