• Prospective multicenter Observational study on Transfusion practice in vv-ECMO Patients: The PROTECMO Study
What and Why?
The PROTECMO study aiimed to provode new insights on the topic of transfusion management of critically ill patients undergoing VV-ECMO.
The optimal management of anticoagulation targets and transfusion practice in veno-venous-ECMO (VV-ECMO) patients is still under debate. Traditionally, the threshold for transfusions of packed red blood cells (PRBC) in ECMO is aimed at keeping hemoglobin (Hb) values in the normal range (12-14 g/dL), but some case series have shown how the Hb target can be lower, and with comparable clinical outcomes.
Recently, in the EOLIA trial, which enrolled patients from 2011 to 2017, the Hb level was set per protocol between 8 and 10 g/dl (with a planned possible increase in the case of persistent hypoxemia), far from the level recommended in the CESAR trial (protocolized between 12 and 14 g/dl), which included patients ten years before.
PROTECMO aimed to highlight what blood products out ECMO patients receive, how and when they are administered in the current evolving equipment scenario for ECMO.
Objectives
The principal aim is to describe current effective blood product usage, during VV-ECMO. The secondary aim is to describe in a large cohort of ECMO patients the current anticoagulation strategy and bleeding episodes occurrence.
How?
Trial Design
The study is designed as a prospective observational multicenter cohort study.
No intervention. No additional tests. All data to be collected from the patient’s file and just data adopted in the current practice of each ECMO center will be recorded.
The data collection will include pre-ECMO characteristics, transfusion strategies and blood test results during the first twenty-eight days after ECMO cannulation or until the end of ECMO support if the length is shorter, and clinical outcomes up to the end of ICU stay.
Inclusion criteria/patient selection
All patients who receive extracorporeal lung support (ECMO) for ARDS respiratory causes will be included. Of note, considering the observational design of our study, patients can be included in other studies concurrently (this will be noted on the CRF).
Exclusion criteria: refusal to include
Jehovah’s witnesses and all patients refusing transfusions for personal reasons will not be excluded, but they will be analyzed separately.
COVID-19 : Report as diagnosis instead of viral pneumonia. The investigator can select “other acute respiratory diagnosis” and specify COVID-19
Duration of the study
12 consecutive months or 20 consecutive VV-ECMO runs per intensive care unit, whichever comes first.
A flexible start of the inclusion period will be allowed for each ICU to facilitate participation in the study. Enrollment of ICU will last until the end of March 2019.
Do I need IRB approval?
Ethical requirements for data collection vary within countries and jurisdictions. Where appropriate, ethical approval and requirement or waiver for consent of participation will be obtained for each country by the country coordinator and where required by the local primary investigator at each site.
The promoting center, IRCCS-ISMETT, based on the Italian Privacy code will ask to relatives and informed consent for the participation in the study and for data protection. The study coordinator may provide a template in English for these consents.
All data will be reported in a centralized online and Web-based fully encrypted database (REDCAP). The study coordinator will regularly contact the local PI to ensure data collection and reporting as well as completion of patient follow-up.
Is there any financial compensation?I
No. Participation in the trial is completely voluntary. In every center 2 investigators will be listed as collaborators; some of the national coordinators, according to the entity of data and type of journal will be listed as authors. The multifaceted aspect of this prospective study will allow probably the publication of more than one manuscript and will give the opportunity for a larger involvements of the investigators.
How do I participate?
Registration is closed.
Financial support
The project has not received any external financial support and is currently supported by IRCCS-ISMETT.
Steering Committee
- Antonio Arcadipane, Gennaro Martucci (IRCCS-ISMETT, Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione, Palermo – Italy)
- Antonio Pesenti, Giacomo Grasselli (University of Milan)
- Daniel Brodie (Columbia University, New York)
- Hergen Buscher (St. Vincent’s Hospital, Sydney, Australia)
- Giuseppe Foti (University of Monza)
- Marco Ranieri (University of Rome)
- Peter Schellongowski (University of Vienna)
- Matthieu Schmidt (University of Paris)
- Kenichi Tanaka (University of Maryland)
National Coordinators
- Italy: G. Panarello, Palermo
- Spain and South America: J. Riera, Barcelona
- France: M. Schmidt, Paris
- Austria: P. Scellongowski, Vienna
- UK: A. Retter, London
- Australia, New Zeland, Asia: H. Buscher, Sydney
Enrollment phase:
CENTERS IN PREPARATION FOR ETHIC COMMITTEE APROVAL
- Maastricht University Hospital
- Charité – Berlin
- Apollo Hospital – Bangalore
- Hospital Sacre-Coeur – Montreal
- Seoul National Univerity Bundang Hospital
- Mater Domini, University Hospital – Catanzaro
- LSU Health Sciences Center-Shreveport
- Hospital UniversitarioRamon y Cajal – Madrid
- Hospital Universitario Son Espases – Palma de Maiorca
- Hospital Clinico Universitario – Murcia
- St. Vincent’s Hospital – Sydney
- Mercy Hospital St. Louis
- Clínica Bazterrica, Argentina
- Hospital Universitario Marqués de Valdecilla – Santander
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
- Saiseikai utsunomiya hospital
- Tokyo Metropolitan Tama Medical Center
- Pusan National University Yangsan Hospital
- Chonbuk National University Medical School
- Chiba University Hospital
- CHRU Lille, Hôpital Roger Salengro
- Zhujiang Hospital, Southern Medical University, China
- University Hospital in Krakow
- Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico city
- Upstate University Hospital
- OHSU, Oregon
- National University Hospital, Singapore
- University of Leuven
- Centre Hospitalier Liege
- University of Sao Paulo
- Instituto do Coração, São Paulo
- Papworth Hospital
Update: Research Grant Presentation at the ELSO Congress on 25 September 2020
The study is closed for data inclusion. You can download the final newsletter here (October2021).
More information, please contact: gmartucci@ismett.edu or aarcadipane@ismett.edu
