CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 850 enrolled
Drug / intervention
Restrictive Transfusion Strategy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02968654
NCT02968654N/ACompleted

Transfusion Strategies in Acute Brain Injured Patients. A Prospective Multicenter Randomized Study.

Erasme University Hospital·interventional·Posted Nov 18, 2016·Updated Sep 7, 2023

In Brief

A clinical study evaluating Restrictive Transfusion Strategy and Liberal Transfusion Strategy for Acute Brain Injury and Blood Transfusion. Completed, enrolled 850 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 18, 2016
Enrollment StartSep 13, 2016
Primary CompletionDec 31, 2022
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 9.6 years ago

Interventions

Restrictive Transfusion Strategyprocedure

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 Strategyprocedure

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.