SPLASH Trial Takes a Dive at Finding Best Tx for Blunt, Splenic Trauma

In patients with splenic trauma at high risk for splenic rupture, 1-month spleen salvage rates were no different with either prophylactic splenic arterial embolization (pSAE) or surveillance and embolization only if necessary (SURV). In fact, both strategies resulted in spleen rescue rates of >93%, according to results from the Splenic Arterial Embolization to Avoid Splenectomy (SPLASH), published in JAMA Surgery.

“Owing to the greater than 80% risk of secondary rupture, preventive embolization of [splenic pseudoaneurysms] SPAs and SAVFs is currently performed as routine practice, as recommended by US and international guidelines and, ethically, cannot be questioned in a randomized clinical trial; nevertheless, for patients at high risk of secondary splenic hemorrhage, such as a large hemoperitoneum and severe damage, practices are still very heterogeneous,” wrote SPLASH researchers, led by Catherine Arvieux, MD, PhD, of Grenoble-Alpes University Hospital, Grenoble, France.

“Nonoperative management of splenic trauma has been recommended for 20 years, but, in practice, secondary splenectomy owing to hemorrhage is often needed,” they added.

Arvieux and colleagues conducted the SPLASH trial, in which they randomized 117 hemodynamically stable patients (median age: 30 years; 78.9% male) with splenic trauma who were at high risk of rupture to either pSAE (n=57) or SURV (n=60). All patients were admitted through emergency departments, shock treatment or intensive care units, or for surgery at 16 trauma centers throughout France. Prophylactic SAEs were performed using an arterial approach via the femoral artery.

At 1 month, the number of patients with at least a 50% viable spleen seen on CT did not differ significantly between patients who underwent pSAE and those who underwent SURV (98.2% versus 93.3%; difference: 4.9%; 95% CI: −2.4% to 12.1%; P=0.37).

By day 5, SPLASH researchers observed fewer SPAs in patients treated with pSAE compared with treated with SURV (1.5% vs 12.3%, respectively; difference: −10.8%; 95% CI: −19.3% to −2.1%; P=0.03), as well as significantly fewer secondary embolizations (1.5% versus 29.2%; difference: −27.7%; 95% CI: −41.0% to −15.9%; P˂0.001).

Urgent re-embolization was necessary in 3.1% of the pSAE group by month 1, and splenic embolization in 32.3% of the SURV group. In the latter, researchers concluded that splenic trauma of OIS grade 4 or greater was a risk factor for delayed intervention.

In addition, there were no significant between-group differences in overall complication rates (29.2% vs 41.5%; difference: −12.3%; 95% CI: −28.3% to 4.4%; P=0.14), or in overall complication rates from day 5 to patients’ 1-month visits (18.6% versus 19.0%; difference: −0.4%; 95% CI: −14.4% to 13.6%; P=0.96) between the two groups.

Median length of hospitalization was 11 days. Patients treated with pSAE, however, had significantly shorter lengths of hospitalization compared with SURV (9 vs 13 days, respectively; P=0.002).

Median WOMAC score—a patient-reported measure of functional activity—did not differ significantly between the two groups at month 1 (P=0.38) or month 6 (P=0.63). Also at 1 month, Arvieux and colleagues found no significant differences in return to work or studies between the pSAE and SURV groups (14.0% versus 11.1%; difference: 2.9%; 95% CI: −11.2 to 16.8%; P=0.69), or in total time off work or studies at 6 months (75.9% versus 61.1%; difference: 13.9%; 95% CI: −8.2% to 36.2%; P=0.21).

“In this trial, the rate of splenic rescue was greater than 93% in both groups, confirming the efficacy of SAE for splenic trauma already reported in the literature. The embolization complication rate in our trial was low, less than 10%. Only 1 case of splenic necrosis involving more than half the volume of the gland occurred in the pSAE group,” concluded Arvieux and colleagues.

Although further studies are needed, these results from Arvieux and fellow researchers are valuable, wrote Shah-Jahan Dodwad, DO, and colleagues, all of the University of Texas Health Science Center at Houston, Houston, TX, in an accompanying editorial.

“The SPLASH trial ultimately does not recommend one management strategy over another but concludes that both prophylactic angioembolization and surveillance are defensible strategies for patients with blunt trauma at high risk for splenic rupture. However, it does provide a starting point for discussions with patients to engage in shared decision-making. Patients who are at high risk for not being able to follow up or those with a grade 4 or 5 injury may wish to consider more seriously prophylactic angioembolization. In the meantime, the SPLASH trial is a refreshing and welcome addition to the observational studies informing the care of patients with blunt trauma,” they noted.

“The authors should be commended for performing a multicenter randomized clinical trial to address the controversy of routine angioembolization for patients at high risk of splenic rupture. The high rate of splenic salvage with nonoperative management, regardless of angioembolization strategy, is reassuring. Although the splenectomy rate might have been a more clinically meaningful primary outcome, the trial would have required significantly more patients and a longer time period to be adequately powered. As it is, the trial was likely underpowered to determine whether there was a difference in complications. Nonetheless, the trial minimizes bias in estimating the relative risks and benefits of the 2 strategies,” concluded Dodwad et al.

Limitations of the SPLASH trial include the lack of data on individual irradiated volumes patients were exposed to, possible underestimation of the sample size, and the possibility of less-than-rigorous post-trauma surveillance.

1. In the SPLASH trial, the rate of splenic rescue was greater than 93% in patients with blunt trauma who were at high risk for splenic rupture with both prophylactic splenic arterial embolization (pSAE) and surveillance and embolization only if necessary (SURV).

2. SPLASH researchers also found similar complication rates, the need for re-embolization, length of hospitalization, and return to activity.

E.C. Meszaros, Contributing Writer, BreakingMED™

Cat ID: 159

Topic ID: 97,159,254,730,118,192,925,159