Highly restrictive vs normal red blood cell transfusion strategy in anemic critically ill patients - A feasibility trial

Highly restrictive vs normal red blood cell transfusion strategy in anemic critically ill patients - A feasibility trial - Very Restrictive Transfusion of Erythrocytes study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57318

Enrollment

Registered

2025-02-12

Start date

2025-08-04

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Interventions

Restrictive red blood cell (RBC) transfusion threshold: in case the Hb transfusion trigger of 5.0 g/dL is reached, 1 RBC unit at a time will be administered. The current transfusion threshold: in ca

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: - patient is aged 18 years or older - deferred informed consent - hemoglobin concentration of 5.0 mmol/L (=8 g/dL) or lower

Exclusion criteria

Exclusion criteria: - Not expected to survive for 24 hours at time of assessment. - Expected to stay in ICU for less than 48 hours. - Inability to receive blood products or known to decline to blood transfusions (e.g., Je-hova*s Witnessess). - Exclusion of specific subgroups: Patients receiving extra-corporeal membrane oxygenation (VV or VA) Patients with an acute coronary syndrome in the past 30 days Patients following cardiac surgery Patients admitted with both traumatic and non-traumatic brain injury (i.e. traumatic subarachnoid hemorrhage, cerebral infarction) Patients with hemoglobinopathies such as sickle cell disease Massive bleeding patients Pregnant patients

Design outcomes

Primary

Measure	Time frame
Primary outcome is feasibility measured by protocol compliance. Protocol compliance is defined as the percentage of red blood cell transfusion initiated below the assigned transfusion threshold.	—

Secondary

Measure	Time frame
Secondary study parameters will include SOFA-score, number of protocol violations and incidence of protocol suspensions divided into any (suspected) major bleeding, necessary transfusion prior to (surgical) intervention and early signs of organ hypo perfusion. Early signs of hypo perfusion is divided into cardiac and elevated lactate levels of more than 4mmol/L (in conjunction with decreased SvO2) which cannot be attributed to other causes besides anemia. Other secondary study parameters include the presence of organ ischemia, use of life support, development of acute kidney injury stage 2 (KDIGO criteria), transfusion practices, 30-day mortality, duration of ICU and hospital stay, ICU re-admission rates and cost effectiveness.	—

Measure

Time frame

Secondary study parameters will include SOFA-score, number of protocol violations and incidence of protocol suspensions divided into any (suspected) major bleeding, necessary transfusion prior to (surgical) intervention and early signs of organ hypo perfusion. Early signs of hypo perfusion is divided into cardiac and elevated lactate levels of more than 4mmol/L (in conjunction with decreased SvO2) which cannot be attributed to other causes besides anemia. Other secondary study parameters include the presence of organ ischemia, use of life support, development of acute kidney injury stage 2 (KDIGO criteria), transfusion practices, 30-day mortality, duration of ICU and hospital stay, ICU re-admission rates and cost effectiveness.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026