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Blood Management During ECMO for Cardiac Support

NCT03714048 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 561

Last updated 2023-04-20

No results posted yet for this study

Summary

Extracorporeal membrane oxygenation (ECMO) is a lifesaving procedure used to treat severe forms of heart and/or lung failure. It works by the principal of replacing the function of these organs by taking blood from the patient, provide it with oxygen outside the body and return it to the patient in one continuous circuit. Because of the evaluability of better technology, the use of ECMO has exponentially risen over the last decade. This treatment is very invasive and carries a number of risks. It is mostly used in situations where it seems likely that the patient would otherwise die and no other less invasive measure could change this. Still in large registries 50-60% of patients die which is often due to complications associated with the treatment.

One of the most important complication is caused by the activation of clotting factors during the contact with the artificial surfaces of the device. This can lead to clot formation inside the patient or the device. To counterbalance this anticoagulation is needed. Because of the consumption of clotting factors and the heparin therapy bleeding complications are also very common in ECMO.

Clinicians are challenged to balance these competing risks and are often forced to transfuse blood products to treat these conditions, which comes with additional risks for the patient. Many experienced centres have reported thromboembolic and bleeding events as the most important contributor to a poor outcome of this procedure. However, no international study combining the experience of multiple centres to compare their practice and identify risk factors which can be altered to reduce these risks.

This study has been endorsed by the international ECMONet and aims to observe the practice in up to 50 centres and 500 patients worldwide to generate the largest ever published database on this topic. It will concentrate on patients with severe heart failure and will be able to identify specific risk factors for thromboembolic and bleeding events. Some of these factors may be modifiable by change in practice and can subsequently be evaluated in clinical trials. Some of these factors may include target values for heparin therapy and infusion of clotting factors.

This study will directly improve patient management by informing clinicians which measures are associated with the best outcome and indirectly helps building trials to increase the evidence further.

Conditions

  • Death, Sudden, Cardiac
  • HEART ARREST
  • Shock, Cardiogenic
  • Arrhythmias, Cardiac
  • Hemorrhage
  • Venous Thrombosis
  • Embolism
  • Blood Transfusion
  • Disseminated Intravascular Coagulation

Sponsors & Collaborators

  • St Vincent's Hospital, Sydney

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-01-15
Completion
2023-04-15

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03714048 on ClinicalTrials.gov