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Impact of COVID-19 on an international randomized trial in critically ill patients with traumatic brain injury: insights from the HEMOTION trial

Year: 2026

Type: article

Abstract: The COVID-19 pandemic disrupted clinical research worldwide, but its impact on the conduct of large international trials in neurocritical care is not well documented. We aimed to assess how the pandemic affected recruitment, consent processes, patient characteristics, and outcomes in the HEMOTION trial, a randomized study comparing liberal and restrictive transfusion strategies in patients with traumatic brain injury (TBI). We conducted a post-hoc observational analysis of the HEMOTION trial. Adults with moderate-to-severe TBI (Glasgow Coma Scale ≤12) and hemoglobin ≤10 g/dL were randomized to liberal (transfusion triggered by a hemoglobin level ≤10 g/dL) or restrictive (transfusion triggered by a hemoglobin level ≤7 g/dL) transfusion strategy. Patients enrolled between September 1, 2017, and April 13, 2023, were compared according to two periods: before the pandemic (Sep 2017–Jan 2020) and during the pandemic (Feb 2020–Apr 2023). The main outcomes of this analysis were screening and recruitment rates and the proportion of consent refusals. Other outcomes included transfusion practices, neurologic outcome at 6 months (Glasgow Outcome Scale–Extended, GOS-E), mortality, quality of life, and hospital-acquired infections. Statistical analyses used nonparametric and hierarchical models. Among 736 trial participants, 203 were recruited before and 533 during the pandemic. Patients enrolled during the pandemic presented with lower Glasgow Coma Scale (GCS) motor scores (median 4 [IQR, 1–5] vs 4 [IQR, 2–5]; p=0.02) and longer time from injury to randomization (60 h [IQR, 41–91] vs 49 h [IQR, 30–78]; p=0.001). Screening rates (p=0.004) and recruitment rates (0.21 [IQR, 0.13–0.29] vs 0.29 [IQR, 0.17–0.57] patients/center/15 days; p=0.01) were lower during the pandemic. Consent refusals increased (28.2% vs 19.1%; risk ratio (RR) 1.47, 95% CI (1.06-2.05) p=0.022) during the pandemic. Six-month GOS-E, mortality, and quality-of-life were similar across periods. Hospital-acquired infections were less frequent during the pandemic (48.4% vs 68.0%; p < 0.001), especially pneumonia (30.2% vs 44.3%; p < 0.001). Despite reduced recruitment and a higher proportion of consent refusals, the HEMOTION trial maintained its feasibility during the pandemic. These results highlight the resilience of research teams and underscore the importance of adaptive strategies to sustain clinical research during public health crises. NCT03260478, Date of registration: 2017-08-22

Source: Trials

DOI: 10.1186/s13063-026-09984-x