Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-04 @ 2:10 AM
Study NCT ID:
NCT03871166
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2019-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001803', 'term': 'Blood Transfusion'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1044}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-30', 'studyFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2019-03-09', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '01/2007 - 12/2018', 'description': 'Mortality of patients with ARDS at 28 days according to transfusion threshold'}], 'secondaryOutcomes': [{'measure': 'Failure-free days composites', 'timeFrame': '01/2007 - 12/2018', 'description': 'Failure-free days composites according to transfusion threshold'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS, Human']}, 'referencesModule': {'references': [{'pmid': '33327953', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with ARDS and admitted to the ICUs of the Charité ARDS center will be enrolled in the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients with ARDS\n* Admission to the Charité ARDS center\n\nExclusion Criteria:\n\n* All patients \\<18 years at the time of admission\n* All patients with ARDS not admitted to the Charité ARDS center'}, 'identificationModule': {'nctId': 'NCT03871166', 'briefTitle': 'Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'RECETTA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood transfusion', 'type': 'OTHER', 'description': '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.\n\nApproximately 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.\n\n\\[Time Frame: 01/2007 - 12/2018\\]'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Jan A Graw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jan Adriaan Graw', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}