The aim of the current study is to determine whether a *liberal* strategy of maintaining Hb concentrations above 9 g/dL would result in a different neurological outcome when compared to a *restrictive* approach to red-cell transfusion to avoid…
ID
Source
Brief title
Condition
- Structural brain disorders
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is neurological outcome, evaluated using extended Glasgow
Outcome Scale (eGOS), at 180 days after the initial injury.
Secondary outcome
Secondary outcomes include, amongst all, 28-day survival, intensive care unit
(ICU) and hospital length of stay, the occurrence of extra-cerebral organ
dysfunction/failure and the development of any infection or thromboembolic
events (either venous or arterial).
Background summary
Although blood transfusions can be lifesaving in severe hemorrhage, they could
also result in several potential complications. As anemia has also been
associated with poor outcome in critically ill patients, optimal transfusion
trigger is a real challenge for clinicians. This is even more important in
patients with acute brain injury who were not specifically evaluated in
previous large randomized clinical trials dealing with the optimal transfusion
threshold. Neurological patients may be particularly sensitive to anemic brain
hypoxia because of the exhausted cerebrovascular reserve, which adjust cerebral
blood flow to tissue oxygen demand.
Study objective
The aim of the current study is to determine whether a *liberal* strategy of
maintaining Hb concentrations above 9 g/dL would result in a different
neurological outcome when compared to a *restrictive* approach to red-cell
transfusion to avoid hemoglobin concentrations < 7 g/dL in critically ill
anemic patients (i.e. Hb <= 9 g/dL) with acute brain injury.
Study design
Prospective, multi-center, randomized, pragmatic, controlled international
study conducted at intensive care units (ICUs).
Intervention
A *liberal* strategy of maintaining Hb concentrations above 9 g/dL will be
compared to a *restrictive* approach to red-cell transfusion to avoid
hemoglobin concentrations < 7 g/dL in critically ill anemic patients (i.e. Hb <=
9 g/dL) with acute brain injury.
Study burden and risks
There is a very small risk of transfusion reactions or infections when blood
transfusions are administered. However, surveillance on both complications will
be strictly applied and standard surveillance for infections are in place as
part of standard practice, minimising infection risks.
Route de Lennik 808
Bruxelles 1070
BE
Route de Lennik 808
Bruxelles 1070
BE
Listed location countries
Age
Inclusion criteria
1. Age >=18 years and <= 80 years
2. Acute Brain Injury: Traumatic Brain Injury; Subarachnoid Hemorrhage;
Intracranial Hemorrhage (ICH: either primary or anticoagulants-associated)
3. Glasgow Coma Score (GCS) on randomization <= 13
4. Expected ICU stay > 72 hours
5. Hemoglobin (Hb) concentration <= 9 g/dL
Exclusion criteria
1. Post-anoxic coma; status epilepticus without underlying brain injury;
central nervous system (CNS) infections (community-acquired; hospital-acquired;
ventriculitis; post-operative)
2. Known previous neurological disease, causing significant cognitive and/or
motor handicap
3. ICH due to artero-venous malformation (AVM) or brain tumor
4. Inability (religious reasons) or reduced ability (lack of compatible blood)
to receive blood products
5. Active and uncontrolled bleeding at the time of enrollment
6. GCS of 3 with both fixed and dilated pupils; Brain death or imminent death
(within 24 hours)
7. Pregnancy
8. Medical need to keep Hb levels > 8-9 g/dL (e.g. active coronary disease or
severe cardiac disease)
9. DNE (do not escalate) orders
10. Previous allo-immunisation due to transfusion limiting RBC availability
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT02968654 |
| CCMO | NL61748.078.18 |