CYCLE

• Research type

  Research Study

• Full title

  The Coagulopathy of Patients Receiving Extracorporeal Membrane Oxygenation

• IRAS ID

  252604

• Contact name

  Beverley Hunt

• Contact email

  beverley.hunt@gstt.nhs.uk

• Sponsor organisation

  Guy's & St Thomas' Hospital NHS Trust

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Summary of Research
  Extracorporeal membrane oxygenation (ECMO) is a medical device used for patients with severe respiratory failure in intensive care to allow oxygenation and carbon dioxide removal whilst their lungs recovered from the condition affecting them. ECMO is associated high rates of bleeding and thrombosis due to changes in the clotting system. These complications cause significant difficulties during the use of ECMO which also requires anticoagulation to allow the device is function.

  At present, there is no consensus on the treatment of these issues. This study aims to give a detailed understanding of the processes causing clotting changes with ECMO. This will allow for better treatment and prevention of thrombosis and bleeding including anticoagulation and blood product use in these patients.

  ECMO is provided by a small number of specialist intensive care units in the UK. This study would be carried out at one of these units for adults over 18 years receiving ECMO. The study will assess clotting parameters around the time of ECMO by taking blood tests at specific times points and will then be correlated to their clinical outcomes including survival, blood product use, bleeding and thrombosis rates. The ECMO devices will also be reviewed microscopically to assess
  for the nature of clots within them

  Summary of Results
  The purpose of the study was to assess the changes in coagulation related to the use of extracorporeal membrane oxygenation (ECMO) in adult patients with severe respiratory failure. There focus was on changes in markers of thrombin generation (the ability to clot), fibrinolysis (the process of clot breakdown) and circulating histone levels (a marker of cellular injury).

  The results showed that there were variable changes in different coagulation markers through ECMO. Prior to starting ECMO, there were elevated markers of PAI-1, tPA, fibrinogen, H3 histones and D-Dimers suggestive of a significant inflammatory response due to critical illness. Subsequent changes showed an early increase in markers of thrombin generation during the first 2 days of ECMO, which remained persistently elevated followed by a subsequent increase in markers of fibrinolysis after 2 days of ECMO. There were also increased histone levels throughout ECMO use suggestive that the ECMO device contributes to cellular injury.

  The results suggest that the various components of coagulation are affected at different timepoints through the use of ECMO and the critical illness of the patients also plays a role.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  19/LO/1016

• Date of REC Opinion

  3 Jul 2019

• REC opinion

  Favourable Opinion