NCT03871166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,044

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

March 9, 2019

Last Update Submit

January 30, 2021

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality of patients with ARDS at 28 days according to transfusion threshold

    01/2007 - 12/2018

Secondary Outcomes (1)

  • Failure-free days composites

    01/2007 - 12/2018

Interventions

Blood transfusionOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients with ARDS and admitted to the ICUs of the Charité ARDS center will be enrolled in the study

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Related Publications (1)

  • Hunsicker O, Materne L, Bunger V, Krannich A, Balzer F, Spies C, Francis RC, Weber-Carstens S, Menk M, Graw JA. Lower versus higher hemoglobin threshold for transfusion in ARDS patients with and without ECMO. Crit Care. 2020 Dec 16;24(1):697. doi: 10.1186/s13054-020-03405-4.

    PMID: 33327953DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Jan A Graw, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2019

First Posted

March 12, 2019

Study Start

August 1, 2018

Primary Completion

July 1, 2020

Study Completion

November 24, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

DE(1)