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Trial record 85 of 397 for:    bleeding episodes

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
Sponsor:
Collaborators:
Medical University of Vienna
University of Maryland
University of Milan
University of Milano Bicocca
Pitié-Salpêtrière Hospital
Hospital Vall d'Hebron
St Vincent's Hospital, Sydney
Columbia University
Guy's and St Thomas' NHS Foundation Trust
Hospital Sao Joao
Azienda Policlinico Umberto I
University of Bari
University of Turin, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Information provided by (Responsible Party):
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

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.


Condition or disease
Extracorporeal Membrane Oxygenation Complication Transfusion Related Complication Hemorrhage Anticoagulant-induced Bleeding

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Descriptive data of PRBC transfusion in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]
    Packed Red Blood Cells Transfused, amount

  2. Descriptive data of Platelets transfusion in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]
    Platelets, amount

  3. Descriptive data of Plasma transfusion in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]
    Plasma, amount

  4. Descriptive data of Fibrinogen administration in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]
    Fibrinogen, amount

  5. Descriptive data of Antithrombin III administration in patients receiving VV-ECMO [ Time Frame: Day 28 after ECMO start ]
    Antithrombin III, amount


Secondary Outcome Measures :
  1. Descriptive data of anticoagulation practices in patients receiving VV-ECMO [ Time Frame: daily for 28 days ]
    Type of anticoagulant adopted during ECMO

  2. Descriptive data of anticoagulation practices in patients receiving VV-ECMO [ Time Frame: daily for 28 days ]
    Dose of anticoagulant adopted during ECMO

  3. Descriptive data of bleeding episodes in patients receiving VV-ECMO [ Time Frame: daily for 28 days ]
    Episodes of bleeding according to site and severity

  4. Correlate the amount of transfusions to clinical outcomes [ Time Frame: Day 28 after ECMO start ]
    ECMO weaning, Yes/Not



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion criteria:

- 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).

Exclusion criteria:

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


Information from the National Library of Medicine

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


Contacts
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Contact: Gennaro Martucci, MD 00393316519877 gmartucci@ismett.edu
Contact: Valentina Agnese, MD 00393316073005 vagnese@ismett.edu

Locations
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Italy
Ismett Recruiting
Palermo, Italy, 90133
Contact: Gennaro Martucci, MD    00393316519877    gmartucci@ismett.edu   
Contact: Antonio Arcadipane, MD    00390912192497    aarcadipane@ismett.edu   
Sponsors and Collaborators
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Medical University of Vienna
University of Maryland
University of Milan
University of Milano Bicocca
Pitié-Salpêtrière Hospital
Hospital Vall d'Hebron
St Vincent's Hospital, Sydney
Columbia University
Guy's and St Thomas' NHS Foundation Trust
Hospital Sao Joao
Azienda Policlinico Umberto I
University of Bari
University of Turin, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Study Director: Antonio Arcadipane, MD IRCCS-ISMETT
Principal Investigator: Gennaro Martucci, MD IRCCS-ISMETT
  Study Documents (Full-Text)

Documents provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:
Informed Consent Form  [PDF] October 1, 2018


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Responsible Party: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier: NCT03815773     History of Changes
Other Study ID Numbers: IRRB/15/17
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:
ECMO
PRBC
Fresh frozen Plasma
Fibrinogen
Antithrombin III
Bleeding
Anticoagulation

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes