PRospective Multicenter Observational Study on Transfusion Practice in Vv-ECMO Patients: The PROTECMO Study (PROTECMO)
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|ClinicalTrials.gov Identifier: NCT03815773|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
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.
|Condition or disease|
|Extracorporeal Membrane Oxygenation Complication Transfusion Related Complication Hemorrhage Anticoagulant-induced Bleeding|
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|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||PRospective Multicenter Observational Study on Transfusion Practice in Vv-ECMO Patients: The PROTECMO Study|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
- Descriptive data of PRBC transfusion in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]Packed Red Blood Cells Transfused, amount
- Descriptive data of Platelets transfusion in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]Platelets, amount
- Descriptive data of Plasma transfusion in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]Plasma, amount
- Descriptive data of Fibrinogen administration in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]Fibrinogen, amount
- Descriptive data of Antithrombin III administration in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]Antithrombin III, amount
- Descriptive data of anticoagulation practices in patients receiving VV-ECMO [ Time Frame: daily for 28 days ]Type of anticoagulant adopted during ECMO
- Descriptive data of anticoagulation practices in patients receiving VV-ECMO [ Time Frame: daily for 28 days ]Dose of anticoagulant adopted during ECMO
- Descriptive data of bleeding episodes in patients receiving VV-ECMO [ Time Frame: daily for 28 days ]Episodes of bleeding according to site and severity
- Correlate the amount of transfusions to clinical outcomes [ Time Frame: Day 28 after ECMO start ]ECMO weaning, Yes/Not
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815773
|Contact: Gennaro Martucci, MDemail@example.com|
|Contact: Valentina Agnese, MDfirstname.lastname@example.org|
|Palermo, Italy, 90133|
|Contact: Gennaro Martucci, MD 00393316519877 email@example.com|
|Contact: Antonio Arcadipane, MD 00390912192497 firstname.lastname@example.org|
|Study Director:||Antonio Arcadipane, MD||IRCCS-ISMETT|
|Principal Investigator:||Gennaro Martucci, MD||IRCCS-ISMETT|