Oxygen Extraction-guided Transfusion in Critically Ill Patients

NCT ID: NCT03767127

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-12-30

Brief Summary

Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the "TRICC" Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb<7 g/dL) had similar mortality to patients transfused if Hb<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.

Conditions

Anemia; Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Appropriate transfusion policy

Patients transfused with high arterial-venous oxygen difference (≥3.7 ml/dl) or non-transfused with low arterial-venous oxygen difference (\<3.7 ml/dl)

No interventions assigned to this group

Non-Appropriate transfusion policy

Patients transfused despite low arterial-venous oxygen difference or non-transfused with high arterial-venous oxygen difference

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Hemoglobin level <10 g/dL during the first 72 hours of ICU

Exclusion Criteria

• Acute bleeding
• Hemoglobin level less than 7 g/dL

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Alberto Fogagnolo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università di Ferrara

Ferrara, , Italy

Countries

Italy

References

Fogagnolo A, Taccone FS, Vincent JL, Benetto G, Cavalcante E, Marangoni E, Ragazzi R, Creteur J, Volta CA, Spadaro S. Using arterial-venous oxygen difference to guide red blood cell transfusion strategy. Crit Care. 2020 Apr 20;24(1):160. doi: 10.1186/s13054-020-2827-5.

Reference Type: DERIVED

PMID: 32312299 (View on PubMed)

Other Identifiers

OEDT

Identifier Type: -

Identifier Source: org_study_id