Blood Transfusion Clinical Trial
— TRAINOfficial title:
Transfusion Strategies in Acute Brain Injured Patients. A Prospective Multicenter Randomized Study.
Verified date | September 2023 |
Source | Erasme University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare a "liberal" and a "restrictive" strategy to administer blood transfusions in critically ill patients with a primary brain injury.
Status | Completed |
Enrollment | 850 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Glasgow Coma Score (GCS) = 13 on randomization - Expected ICU stay > 72 hours - hemoglobin (Hb) concentration = 9 g/dL within 10 days from brain injury 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 arterio-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 pupils fixed and dilated; brain death or imminent death (within 24 hours) 7. Pregnancy 8. Medical need to correct anemia (e.g., active coronary disease or severe cardiac disease) with target Hb levels > 9 g/dL 9. do-not-escalate (DNE) orders 10. Previous allo-immunization due to transfusion, limiting red blood cells (RBC) availability |
Country | Name | City | State |
---|---|---|---|
Belgium | Hopital Erasme | Brussels |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital | European Society of Intensive Care Medicine |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unfavorable Neurological Outcome | Unfavorable neurological outcome is defined by the extended Glasgow Outcome Scale (eGOS) of 1-5 | 180 days after randomization | |
Secondary | Survival | 28 days Survival | 28 days | |
Secondary | Changes in the Glasgow Coma Score (GCS) over time | modification of GCS from admission over the first week and vs. the last available | 28 days | |
Secondary | ICU length of stay | length of ICU stay | 180 days | |
Secondary | Hospital length of stay | length oh hospital stay | 180 days | |
Secondary | Presence and severity of extra-cerebral organ dysfunction/failure | Daily sequential organ failure assessment (SOFA) score | 28 days | |
Secondary | Infection rate | Occurrence of any infection over the first 28 days after randomization | 28 days | |
Secondary | Composite outcome | Death and Organ Failure (defined as at least one extra-cerebral organ failure, according to the specific SOFA sub-score > 2) | 28 days | |
Secondary | Brain Oxygen Pressure | Absolute values of brain oxygen pressure (PbO2) for those patients where this neuromonitoring has been implemented, according to the decision of the attending physician | 28 days | |
Secondary | Daily Fluid Balance | Assessment of the daily fluid balance | 28 days | |
Secondary | Serious Adverse Events (SAE) | Any of the "SAE" as described in the study protocol | 28 days |
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