Predictors of Retained Hemothorax in Trauma: Results of an EAST Multi-Institutional Trial.

BACKGROUND: The natural history of traumatic hemothorax (HTX) remains unclear. We aimed to describe outcomes of HTX following tube thoracostomy drainage and to delineate factors that predict progression to a retained hemothorax (RH). We hypothesized that initial large volume HTX predicts the development of an RH. METHODS: We conducted a prospective, observational multi-institutional study of adult trauma patients diagnosed with a HTX identified on CT scan with volumes calculated at time of diagnosis. All patients were managed with tube thoracostomy drainage within 24 hours of presentation. RH was defined as blood-density fluid identified on follow-up CT scan or need for additional intervention after initial tube thoracostomy placement for HTX. RESULTS: 369 patients who presented with a HTX initially managed with tube thoracostomy drainage were enrolled from 17 trauma centers. RH was identified in 106 (28.7%) patients. Patients with RH had a larger median [IQR] HTX volume on initial CT compared to no RH (191 [48-431] mL vs. 88 [35-245] mL, p = 0.013) and were more likely to be older with a higher burden of thoracic injury. After controlling for significant differences between groups, RH was independently associated with a larger HTX on presentation, with a 15% increase in risk of RH for each additional 100 mL of HTX on initial CT imaging (OR 1.15, 95% CI 1.08-1.21; p \u3c 0.001). Patients with an RH also had higher rates of pneumonia and longer hospital length of stay than those with successful initial management. RH was also associated with worse functional outcomes at discharge and first outpatient follow-up. CONCLUSION: Larger initial HTX volumes are independently associated with RH and unsuccessful initial management with tube thoracostomy is associated with worse patient outcomes. Future studies should use this experience to assess a range of options for reducing the risk of unsuccessful initial management. LEVEL OF EVIDENCE: III, therapeutic/care management study

The unrestricted global effort to complete the COOL trial

Background Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. A further therapeutic option may be open abdomen (OA) management with negative peritoneal pressure therapy (NPPT) to remove inflammatory ascites and attenuate the systemic damage from SCIAS, although there are definite risks of leaving the abdomen open whenever it might possibly be closed. This potential therapeutic paradigm is the rationale being assessed in the Closed Or Open after Laparotomy (COOL trial) (https://clinicaltrials.gov/ct2/show/NCT03163095). Initially, the COOL trial received Industry sponsorship; however, this funding mandated the use of a specific trademarked and expensive NPPT device in half of the patients allocated to the intervention (open) arm. In August 2022, the 3 M/Acelity Corporation without consultation but within the terms of the contract canceled the financial support of the trial. Although creating financial difficulty, there is now no restriction on specific NPPT devices and removing a cost-prohibitive intervention creates an opportunity to expand the COOL trial to a truly global basis. This document describes the evolution of the COOL trial, with a focus on future opportunities for global growth of the study.Methods The COOL trial is the largest prospective randomized controlled trial examining the random allocation of SCIAS patients intra-operatively to either formal closure of the fascia or the use of the OA with an application of an NPPT dressing. Patients are eligible if they have free uncontained intraperitoneal contamination and physiologic derangements exemplified by septic shock OR severely adverse predicted clinical outcomes. The primary outcome is intended to definitively inform global practice by conclusively evaluating 90-day survival. Initial recruitment has been lower than hoped but satisfactory, and the COOL steering committee and trial investigators intend with increased global support to continue enrollment until recruitment ensures a definitive answer.Discussion OA is mandated in many cases of SCIAS such as the risk of abdominal compartment syndrome associated with closure, or a planned second look as for example part of "damage control"; however, improved source control (locally and systemically) is the most uncertain indication for an OA. The COOL trial seeks to expand potential sites and proceed with the evaluation of NPPT agnostic to device, to properly examine the hypothesis that this treatment attenuates systemic damage and improves survival. This approach will not affect internal validity and should improve the external validity of any observed results of the intervention. Trial registration: National Institutes of Health (https://clinicaltrials.gov/ct2/show/NCT03163095). Keywords Intraperitoneal sepsis, Septic shock, Peritonitis, Open abdomen, Multiple organ dysfunction, Laparotomy, Randomized controlled trial, Global healthPeer reviewe