To evaluate the feasibility of enrolling patients in a randomized controlled trial (RCT) comparing endovascular coils (EC) and vascular plugs (VP) for proximal splenic artery embolization (pSAE) in high-grade splenic trauma, and to collect data to inform the design of a larger clinical effectiveness trial.
Single-center, prospective, RCT of patients with Grade III–V splenic injuries selected for nonoperative management. Patients were randomized to pSAE with EC or VP. The main outcome was feasibility. We also evaluated technical success, time to stasis, complications, mortality, and splenectomy rates, by estimating rates and 95% confidence intervals.
46 of 50 eligible patients were enrolled (92%, 95% CI 90–100%). Overall, splenic salvage was 98% (45/46; 95% CI 94–100%). Primary technical success was observed in 22 EC patients (96%; 95% CI 87–100%) and 20 VP patients (87%; 95% CI 73–100%). Bayesian analysis suggests a > 80% probability that primary technical success is higher for EC. Two complications (one major and one minor) occurred in the EC group (9%; CI 0–20%) and one major complication occurred in the VP group (4%; CI 0–13%).
Randomized comparisons of endovascular devices used for pSAE after trauma are feasible. pSAE using either EC or VP results in excellent rates of splenic salvage in trauma patients with high-grade splenic injuries. These high rates of splenic salvage and low rates of complications make their use as a primary outcome in a future trial problematic. Consideration should be given to technical parameters as a primary outcome for future trials.
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The authors would like to acknowledge the efforts of Drs. Ahmed K. Abdel Aal, Husameddin El-Khudari, Annie Lim, Rachel F. Oser, Souheil Saddekni, and Aliaksei Salei for their support in enrolling patients in this trial. The authors would also like to acknowledge the administrative support of Ms. Rebecca Lee.
The work was funded by a Soto Catalyst Award from the University of Alabama at Birmingham.
Conflict of interest
Andrew J. Gunn and Jan O. Jansen receive research support from Penumbra, Inc, but this study was not funded by the company. Andrew J. Gunn is a speaker for Boston Scientific and Terumo. Andrew J. Gunn is a consultant for Varian and Boston Scientific. None of the other authors have a conflict of interest to report.
The study was approved by our institutional review board (IRB) at the University of Alabama at Birmingham. All patients or their representatives provided consent to participate. Consent is not required for publication.
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Gunn, A.J., Raborn, J.R., Griffin, R. et al. A pilot randomized controlled trial of endovascular coils and vascular plugs for proximal splenic artery embolization in high-grade splenic trauma. Abdom Radiol 46, 2823–2832 (2021). https://doi.org/10.1007/s00261-020-02904-w
- Randomized trial