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Randomized Controlled Trial
. 2019 Mar 12;23(1):89.
doi: 10.1186/s13054-018-2273-9.

Transfusion requirements after head trauma: a randomized feasibility controlled trial

André L N Gobatto  1   2   3 , Milena A Link  3 , Davi J Solla  4 , Estevão Bassi  5   6 , Paulo F Tierno  5 , Wellingson Paiva  4 , Fabio S Taccone  7 , Luiz M Malbouisson  8   9
Affiliations
Randomized Controlled Trial

Transfusion requirements after head trauma: a randomized feasibility controlled trial

André L N Gobatto et al. Crit Care. .

Abstract

Background: Anemia is frequent among patients with traumatic brain injury (TBI) and is associated with an increased risk of poor outcome. The optimal hemoglobin concentration to trigger red blood cell (RBC) transfusion in patients with TBI is not clearly defined.

Methods: All eligible consecutive adult patients admitted to the intensive care unit (ICU) with moderate or severe TBI were randomized to a "restrictive" (hemoglobin transfusion threshold of 7 g/dL), or a "liberal" (threshold 9 g/dL) transfusion strategy. The transfusion strategy was continued for up to 14 days or until ICU discharge. The primary outcome was the mean difference in hemoglobin between groups. Secondary outcomes included transfusion requirements, intracranial pressure management, cerebral hemodynamics, length of stay, mortality and 6-month neurological outcome.

Results: A total of 44 patients were randomized, 21 patients to the liberal group and 23 to the restrictive group. There were no baseline differences between the groups. The mean hemoglobin concentrations during the 14-day period were 8.4 ± 1.0 and 9.3 ± 1.3 (p < 0.01) in the restrictive and liberal groups, respectively. Fewer RBC units were administered in the restrictive than in the liberal group (35 vs. 66, p = 0.02). There was negative correlation (r = - 0.265, p < 0.01) between hemoglobin concentration and middle cerebral artery flow velocity as evaluated by transcranial Doppler ultrasound and the incidence of post-traumatic vasospasm was significantly lower in the liberal strategy group (4/21, 3% vs. 15/23, 65%; p < 0.01). Hospital mortality was higher in the restrictive than in the liberal group (7/23 vs. 1/21; p = 0.048) and the liberal group tended to have a better neurological status at 6 months (p = 0.06).

Conclusions: The trial reached feasibility criteria. The restrictive group had lower hemoglobin concentrations and received fewer RBC transfusions. Hospital mortality was lower and neurological status at 6 months favored the liberal group.

Trial registration: ClinicalTrials.gov, NCT02203292 . Registered on 29 July 2014.

Keywords: Anemia; Transfusion; Traumatic brain injury.

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Conflict of interest statement

Ethics approval and consent to participate

The study was conducted in accordance with the amended Declaration of Helsinki. Local institutional review boards approved the protocol (Comissão de Ética para Análise de Projetos de Pesquisa – CAPPesq, reference number 706744) and written informed consent was obtained from all the patients or their surrogates.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Screening and enrollment
Fig. 2
Fig. 2
Mean daily hemoglobin concentrations in the liberal and restrictive strategy groups during the first 14 days after intensive care unit (ICU) admission (ADM)
Fig. 3
Fig. 3
Neurological status at hospital discharge and at 6 months after hospital discharge as measured by the Glasgow Outcome Scale
See this image and copyright information in PMC

Comment in

References

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