PRospective Multicenter Observational Study on Transfusion Practice in Vv-ECMO Patients: The PROTECMO Study

Summary

Background: Over the past decade, the use of extracorporeal membrane oxygenation (ECMO) for respiratory support in adults has increased. Several trials have highlighted how red blood cells transfusion can cause several negative effects and, currently, a restrictive transfusion trigger in critically ill patients is widely accepted.

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.

While there are extensive reviews on predicted ECMO survival, and management (even with many debated issues), there is a significant knowledge gap in understanding the benefits and risks of transfusions during VV-ECMO Methods/Design: Prospective observational multicenter study. 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.

The study will be conducted at a multicenter level including in each center all consecutive adult vv-ECMO patients during one year up. 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.

The descriptive variable end points for the primary aim will be the daily and the total amount of PRBC and other blood products (Plasma, Platelets, Fibrinogen, Antithrombin III).

The descriptive variable end points for the secondary aim will be the type and dose of anticoagulation, and episodes of bleeding according to site and severity.

Expected Results: A collaborative combination of ECMO centers will evaluate prospective data of transfusion practices during ECMO. The investigators would be able to describe the currently strategy for administration of blood products, anticoagulation and the effective incidence of bleeding episodes worldwide.

Conditions

• Extracorporeal Membrane Oxygenation Complication
• Transfusion Related Complication
• Hemorrhage
• Anticoagulant-induced Bleeding

Sponsors & Collaborators

• Medical University of Vienna

  collaborator OTHER

• University of Maryland, College Park

  collaborator OTHER

• University of Milan

  collaborator OTHER

• University of Milano Bicocca

  collaborator OTHER

• Pitié-Salpêtrière Hospital

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• St Vincent's Hospital, Sydney

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Hospital Sao Joao

  collaborator OTHER

• Azienda Policlinico Umberto I

  collaborator OTHER

• University of Bari

  collaborator OTHER

• University of Turin, Italy

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  lead OTHER

Principal Investigators

• Antonio Arcadipane, MD · The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

• Gennaro Martucci, MD · The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-01

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Italy

Study Locations