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

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

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Trials
Published
2026-09-10
DOI
https://doi.org/10.1186/s13063-026-09984-x
Primary Topic
Traumatic Brain Injury and Neurovascular Disturbances
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article
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article

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

Sikhangezile Gwatikunda, Rebecca Grey, Xavier Neveu, Rebecca Porteous et al.
Trials
Traumatic Brain Injury and Neurovascular Disturbances
article

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

Sikhangezile Gwatikunda, Rebecca Grey, Xavier Neveu, Rebecca Porteous, Stéphane Hecketsweiler, Elisabeth Canitrot, François Lauzier, Rayhaneh Rahgoshai, Shane English, Ian Turner-Bone, David Bellemare, Élaine Carbonneau, Cecilia Peters, Lucie Vettoretti, Noémie Villemure‐Poliquin, Audrey Ambert, Minerva Gellamucho, Leora Hiar, Irene Watpool, Lucy Clayton, Tayne Hewer, Nicole Marinoff, Tracy Boyd, Ana Paula de Carvalho Canela Balzi, Maggie Wilson, Luiz M Malbouisson, Rhys Davies, Olivier Costerousse, Amal Mohammed, Lauren Simpson, Eileen Campbell, Valerie Barrette, Beatriz Costa Duarte da Conceição, Annemarie Docherty, Marlene Santos, Reece Doonan, Amanda Martyniuk, Fabiana Agena, Danielle Tapps, Sébastien Pili-Floury, Dean A. Fergusson, Sarah Clark, Marie-Pier Patton, Marc-Aurèle Gagnon, Gayle Carney, the Canadian Critical Care Trials Group, the HEMOTION Trial investigators, Elodie Caumon, Marwan Bouras, Alexis F. Turgeon, Tim Walsh, Chartelin Jean-Isaac
article en

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

Trials
Western University (CA), Island Health (CA), St. Michael's Hospital (CA), Dalhousie University (CA), Sunnybrook Health Science Centre (CA), Nottingham University Hospitals NHS Trust (GB), University of Liverpool (GB), Imperial College Healthcare NHS Trust (GB), University of Ottawa (CA), University of Alberta (CA), University of Calgary (CA), Queen's University (CA), Liverpool Heart and Chest Hospital NHS Trust (GB), Montreal General Hospital (CA), Royal Stoke University Hospital (GB), Ottawa Hospital (CA), University Hospital of Wales (GB), James Cook University Hospital (GB), McGill University Health Centre (CA), Centre Hospitalier Universitaire de Sherbrooke (CA), Health Sciences Centre (CA), Royal Liverpool University Hospital (GB), Vancouver General Hospital (CA), Walton Centre (GB), Centre Hospitalier Universitaire de Besançon (FR), St Michael’s Hospital (IE), The Quebec Population Health Research Network (CA), St Mary's Hospital (GB), Salford Royal Hospital (GB), Hospital Nossa Senhora da Conceição (BR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Centre Hospitalier Régional Universitaire de Brest (FR), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR), Hôpitaux Universitaires de Strasbourg (FR), Hôpital d'Hautepierre (FR), The Queen's Medical Research Institute (GB), St. Mary's Hospital (GB), Université Laval (CA), Ottawa Hospital Research Institute (CA), Université de Nîmes (FR), The University of Winnipeg (CA), University of Wales (GB), McMaster University (CA), University of Edinburgh (GB)
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Traumatic Brain Injury and Neurovascular Disturbances
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