Haemostatic markers in ECMO (HAE) study
Research type
Research Study
Full title
Prospective cohort study of haemostatic activation markers and correlation with bleeding and thrombotic complications in patients receiving extracorporeal membrane oxygenation(ECMO)
IRAS ID
235036
Contact name
Deepa Jayakody Arachchillage
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
RESEARCH SUMMARY:
Extracorporeal membrane oxygenation (ECMO) and ventricular assist devices (VAD) are techniques increasingly used to provide support to patients with severe refractory cardiac and respiratory failure. Despite increasing experience with ECMO and VAD recent technical improvements, bleeding and clotting complications are now a leading cause of morbidity and mortality in these patients. Intracranial haemorrhage (ICH) has been reported with an incidence ranging from 5% up to 19%, with a predominantly fatal outcome. \nWe do not fully understand why these problems are so common although there are many possible factors, including the fact that these patients are already very ill and that anti-coagulant drugs are needed to stop blockage of the blood circuits. \nIn this study we propose simply to measure a number of aspects of blood clotting in patients undergoing ECMO whilst at the same time closely monitoring them bleeding and thrombotic complications \nOur rationale is that better definition of the changes in coagulation parameters and their relation to bleeding mainly intracranial haemorrhage (ICH) and thrombosis will allow us to formulate better protocols for managing these patients. Based on our study findings, a large multicentre prospective study will be designed to assess the benefit of early interventions based on our measurements to reduce the risk of ICH as well as other bleeding and thrombotic complications in patients receiving mechanical circulatory or ventilator support with ECMO or VAD.\n
Summary Study Results:
Patients with severe lung or hear failure are supported by extracorporeal membrane oxygenation (ECMO). During ECMO, blood is pumped outside of your body to a heart-lung machine that removes carbon dioxide and sends oxygen-filled blood back to tissues in the body. Therefore, blood is constant contact with artificial surface which can cause activation of clotting proteins causing increased risk of clot formation (thrombosis) in the ECMO circuit or within the patient. To prevent this , patients receive blood thinning medications (anticoagulants) which can cause increased of bleeding. Furthermore, there are multiple other factors that can contribute to increase risk thrombosis and bleeding in patients supported by ECMO. In this prospective pilot study, we aimed to determine the changes in haemostasis during ECMO and correlation with major bleeding and thrombosis.
Mean age was 45.2 ±11.4yrs and 60% were male. Median (range) on ECMO was 9.5days (5-29). Most of clotting fell with nadirs at day 25 on ECMO which was the longest ECMO duration sampled. Post-decannulation and 24hrs post ECMO, these factors returned to day0 levels or above. 27%(6/22), 54%(12/22) and 32%(7/22) patients respectively had circuit change, thrombosis, and MB. Circuit changes and major bleeding associated with longer ECMO (21.5 vs 9.6,p=0.0001 and 18.4 vs 10.3,p=0.012; days respectively) but with thrombosis (14.5 vs 10.9 days, p=0.27). Major bleeding and thrombosis occurred in 32% and 54% patients respectively. Intrinsic coagulation factors reduced gradually during ECMO and returned to baseline 24hrs after removing from ECMO in majority of the patients.REC name
London - South East Research Ethics Committee
REC reference
18/LO/0183
Date of REC Opinion
8 May 2018
REC opinion
Further Information Favourable Opinion