Oxygen Extraction-guided Transfusion in Critically Ill Patients

Anemia Clinical Trial

Official title:

Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767127
• Other study ID #: OEDT
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2019
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: December 30, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Critical Illness

Locations

Country	Name	City	State
Italy	Università di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day mortality	mortality	after 90 days from study enrollment
Secondary	Acute kidney injury	Occurence of acute kidney injury according to KDIGO 2012 guidelines	7 days after study inclusion
Secondary	Length of ICU stay		from ICU admission to discharge, up to 8 weeks
Secondary	Variation in Sequential Organ Failure Assessment (SOFA) score	daily variation in SOFA score (0-24 points scale with higher values indicating worst conditions)	5 days
Secondary	Days of vasopressor	Need for vasopressor	28 days after study inclusion