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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02968654
Other study ID # P2015/327
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 13, 2016
Est. completion date June 30, 2023

Study information

Verified date September 2023
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare a "liberal" and a "restrictive" strategy to administer blood transfusions in critically ill patients with a primary brain injury.


Description:

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Other known NCT identifiers
  • NCT02962349

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Restrictive Transfusion Strategy
Patients will be randomized when hemoglobin levels will be below 9 g/dl. Patients randomized to the "Restrictive Transfusion Strategy" will receive blood transfusion whenever their Hb concentration is < 7 g/dl. All patients should preferably receive one unit of blood transfusion at a time. The duration of the intervention is 28 days after randomization or until hospital discharge. Daily assessment of hemoglobin levels are mandatory only during the ICU stay. No other procedures and or interventions are scheduled. General management of patients will be conducted according to international guidelines; however, local protocols and procedures are allowed.
Liberal Transfusion Strategy
Patients will be randomized when hemoglobin levels will be below 9 g/dl. Patients randomized to the "Liberal Transfusion Strategy" will receive blood transfusion whenever their Hb concentration is < 7 g/dl. All patients should preferably receive one unit of blood transfusion at a time. The duration of the intervention is 28 days after randomization or until hospital discharge. Daily assessment of hemoglobin levels are mandatory only during the ICU stay. No other procedures and or interventions are scheduled. General management of patients will be conducted according to international guidelines; however, local protocols and procedures are allowed.

Locations

Country Name City State
Belgium Hopital Erasme Brussels

Sponsors (2)

Lead Sponsor Collaborator
Erasme University Hospital European Society of Intensive Care Medicine

Country where clinical trial is conducted

Belgium, 

Outcome

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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