The primary objective is feasibility of a prospective randomized trial, to investigate whether a more restrictive RBC transfusion strategy of 5.0 g/dL (3.1 mmol/L) is non-inferior compared to the current transfusion threshold of 7.0 g/dL (4.3mmol/L…
ID
Source
Brief title
Condition
- Red blood cell disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Red blood cell transfusion is considered a life-saving intervention. Over the
past 20 years however, its potential for harm and even life-threatening
complications have become apparent. Research in various patient groups has
consistently shown that a restrictive transfusion policy, with a hemoglobin
(Hb) threshold of approximately 7.0 g/dL is safe or even associated with better
outcomes. As a result, this has become the standard transfusion trigger.
However, clinical observations indicate the potential for further lowering the
transfusion threshold. This encourages us to investigate the possibility of
adopting an even more restrictive transfusion threshold.
Study objective
The primary objective is feasibility of a prospective randomized trial, to
investigate whether a more restrictive RBC transfusion strategy of 5.0 g/dL
(3.1 mmol/L) is non-inferior compared to the current transfusion threshold of
7.0 g/dL (4.3mmol/L).
Study design
Prospective randomized controlled feasibility trial
Intervention
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 case the Hb transfusion
trigger of 7.0 g/dL is reached, 1 RBC unit at a time will be administered.
Study burden and risks
Anemia and red blood cell transfusions have been linked to higher morbidity and
mortality rates in ICU patients. This patient population is already vulnerable
with a high morbidity and mortality rate. Therefore, it is important to only
transfuse when necessary.
This trial will assess the feasibility of reducing the transfusion threshold
from 7.0 g/dL to 5.0g/dL. Participation in this trial will result in negligible
burden. No additional blood samples are required, as routine blood sampling is
hospital SOP and additional measurements can be included herein. Additional
measurements include a daily ECG as well as urine output assessment, which are
non-invasive. The intervention for this study will only occur during ICU
admission. Given the high incidence of both transfusions and anemia in this
patient population, there are no additional risks associated with either of
these factors.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86532.018.24 |