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Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03871166
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : October 3, 2019
Information provided by (Responsible Party):
Jan Adriaan Graw, Charite University, Berlin, Germany

Brief Summary:
Retrospective analysis of hemoglobin concentrations and red cell transfusion thresholds in patients with an Acute Respiratory Distress Syndrome (ARDS) admitted to an ARDS-center of a German university hospital.

Condition or disease Intervention/treatment
ARDS, Human Other: Blood transfusion

Detailed Description:

Transfusion of packed red blood cells is a common procedure in critically ill patients. In recent years it has been shown that for many patient populations a restrictive transfusion strategy is not inferior compared to a liberal transfusion strategy with regard to overall outcome.

So far it is unclear whether patients with an ARDS should receive blood transfusions according to a restrictive or liberal transfusion strategy. Besides pulmonary gar exchange and cardiac output, the hemoglobin concentration is an important determinant for oxygen delivery.

The aim of this retrospective observational study is to analyze if low levels of hemoglobin/a restrictive transfusion strategy and are associated with a different mortality compared to higher levels of hemoglobin/a liberal transfusion strategy in patients with an ARDS.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 1, 2019

Intervention Details:
  • Other: Blood transfusion

    Observational post-ad-hoc design to compare patients admitted with an ARDS and separated into different groups according to their mean hemoglobin concentration during their stay on the intensive care unit.

    Approximately 1000 adult patients admitted from 2007 to 2018 to the Charite ARDS center will be enrolled in the study. They are followed up until their discharge from the ICU.

    [Time Frame: 01/2007 - 12/2018]

Primary Outcome Measures :
  1. Mortality [ Time Frame: 01/2007 - 12/2018 ]
    Mortality of patients with ARDS at 28 days according to transfusion threshold

Secondary Outcome Measures :
  1. Failure-free days composites [ Time Frame: 01/2007 - 12/2018 ]
    Failure-free days composites according to transfusion threshold

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
Sampling Method:   Probability Sample
Study Population
All adult patients with ARDS and admitted to the ICUs of the Charité ARDS center will be enrolled in the study

Inclusion Criteria:

  • All adult patients with ARDS
  • Admission to the Charité ARDS center

Exclusion Criteria:

  • All patients <18 years at the time of admission
  • All patients with ARDS not admitted to the Charité ARDS center

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 identifier (NCT number): NCT03871166

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Contact: Jan A Graw, MD +4930450551001
Contact: Oliver Hunsicker, MD +4930450551001

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Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Contact: Oliver Hunsicker, MD    +4930450551001   
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Jan A Graw, MD Charite University, Berlin, Germany

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Responsible Party: Jan Adriaan Graw, Principal Investigator, Charite University, Berlin, Germany Identifier: NCT03871166     History of Changes
Other Study ID Numbers: RECETTA
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury