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

NCT03815773 | Completed DMC

• 1 other identifier: IRRB/15/17
• Study Type: observational
• Target: 656
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ECMO; PRBC; Fresh frozen Plasma; Fibrinogen; Antithrombin III; Bleeding; Anticoagulation

Outcome Measures

Primary Outcomes (5)

• Descriptive data of PRBC transfusion in patients receiving VV-ECMO

  Packed Red Blood Cells Transfused, amount

  Day 28 after ECMO start

• Descriptive data of Platelets transfusion in patients receiving VV-ECMO

  Platelets, amount

  Day 28 after ECMO start

• Descriptive data of Plasma transfusion in patients receiving VV-ECMO

  Plasma, amount

  Day 28 after ECMO start

• Descriptive data of Fibrinogen administration in patients receiving VV-ECMO

  Fibrinogen, amount

  Day 28 after ECMO start

• Descriptive data of Antithrombin III administration in patients receiving VV-ECMO

  Antithrombin III, amount

  Day 28 after ECMO start

Secondary Outcomes (4)

• Descriptive data of anticoagulation practices in patients receiving VV-ECMO

  daily for 28 days

• Descriptive data of anticoagulation practices in patients receiving VV-ECMO

  daily for 28 days

• Descriptive data of bleeding episodes in patients receiving VV-ECMO

  daily for 28 days

• Correlate the amount of transfusions to clinical outcomes

  Day 28 after ECMO start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is prospective and, consequently, in each center all consecutive VV-ECMO adult patients who are eligible according to inclusion and exclusion criteria should be included in the study.

You may qualify if:

• \- All consecutive patients who receive veno-venous ECMO for respiratory causes. Of note, considering the observational design of our study, patients can be included in other studies concurrently (this will be noted on the CRF).

You may not qualify if:

• \- Refusal to include expressed by the relatives when tha patient is unconscious or by the patient when he is recovered.

Sponsors & Collaborators

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: lead
• Medical University of Vienna: collaborator
• University of Maryland, College Park: collaborator
• University of Milan: collaborator
• University of Milano Bicocca: collaborator
• Pitié-Salpêtrière Hospital: collaborator
• Hospital Vall d'Hebron: collaborator
• St Vincent's Hospital, Sydney: collaborator
• Columbia University: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Hospital Sao Joao: collaborator
• Azienda Policlinico Umberto I: collaborator
• University of Bari: collaborator
• University of Turin, Italy: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

Ismett

Palermo, 90133, Italy

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Arcadipane, MD

  The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  STUDY DIRECTOR

• Gennaro Martucci, MD

  The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 24, 2019
• Study Start: December 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)