Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05008172 |
| Other study ID # |
PRO00040687 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Medical College of Wisconsin |
| Contact |
Margo Mantz-Wichman, BS RN |
| Phone |
414-955-1751 |
| Email |
mmantzwichman[@]mcw.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Nonoperative management (NOM) of blunt splenic injuries has been the standard of care for
decades. While many splenic injuries can be successfully observed, studies have demonstrated
increased failure rates for higher grade injuries, which prompted some institutions to
perform SAE prophylactically. The current literature comparing observation and SAE is limited
to observational data and is frequently inconsistent. As such, the standard of care varies
across institutions and both strategies are considered acceptable management for splenic
injuries. Our own institution does not routinely perform SAE and our splenic salvage rate
exceed 90% but the investigators noted an increased rate of NOM failure in patients with a
contrast blush on CT. Contrast blush is a known risk factor for NOM failure and has been
cited as a reason to perform SAE, but even within this population no randomized trials have
been performed to demonstrate if SAE improves outcomes. The purpose of this project is to
provide definitive high-quality evidence for the effectiveness of SAE to decrease the rate of
NOM failure in high grade splenic injuries.
Description:
Background
The spleen is the most commonly injured organ in patients who sustain blunt abdominal
trauma.[1] Splenic trauma management has evolved significantly over the past 40 years, with
non-operative management (NOM) considered the standard of care due to the decrease in
morbidity, shorter length of hospitalization, and preservation of splenic function.[2] There
are several controversial topics in the management of blunt splenic injuries (BSI) but the
utilization of splenic artery embolization (SAE) in NOM is perhaps the biggest one.[3]
Proponents of SAE cite higher success rates for NOM and some have even advocated that it
should always be used in the following situations: 1) presence of contrast ¨blush¨ or
extravasation on CT or angiography, 2) AAST Grade 3 injuries associated with moderate amount
of hemoperitoneum, or 3) Patients with AAST Grade 4-5 injuries.[4] These criteria have never
been validated prospectively and are simply associated with a higher risk for NOM failure.
Opponents to SAE cite that this invasive approach has no effect on successful observation and
that it is associated with higher complication rates (splenic infarction, splenic abscess,
puncture site issues) when compared to observation alone.[5-7] There is limited evidence to
guide the decision regarding SAE vs observation in patients sustaining high-risk BSI.
Numerous observational studies on the role of SAE in splenic injury management have been
published but their findings are inconclusive and often contradictory.[8, 9] Considering the
inconsistent evidence and the lack of any high-quality data to inform best practice, clinical
equipoise is achieved and a randomized controlled trial comparing observation to SAE is
justified. Data from our own institution has shown that the presence of a contrast blush is
associated with a much higher NOM failure rate (unpublished data). Based off that finding the
investigators hypothesize that prophylactic SAE will improve NOM success in patients with
high-risk BSI.
The contemporary management of splenic injury
The contemporary management of BSI began in the mid-1980's when the surgeons began publishing
their data on NOM of splenic trauma in children. The adult trauma surgeons subsequently began
using this approach when CT technology allowed for identification and classification of solid
organ injuries.[10] The American Association for Surgery of Trauma (AAST) developed and
subsequently validated a splenic injury grading scale, which provided a standardized
nomenclature for those treating patients with BSI.[11, 12] In addition, the AAST grade was
shown to correlate with risk of NOM failure and also allowed institutions to benchmark their
splenic salvage rates. With increased success in NOM there were subsequent improvements in
other clinical outcomes including lower rates of blood transfusion and decreased length of
stay.[13]
NOM does carry some risks, the most significant of which is delayed splenic rupture.
Typically occurring within 72-hours, delayed splenic rupture is a potentially
life-threatening event that usually requires splenectomy.[14] Failure of NOM also occurs
because of persistent bleeding, an ongoing transfusion requirement, or worsening abdominal
pain that prompts the surgeon to perform a splenectomy. Since the advent of NOM, researchers
have worked to identify the risk factors associated with failure. Increasing age, amount of
hemoperitoneum, grade of organ injury, and presence of contrast extravasation have all been
associated with NOM failure.[14, 15] While none of these are absolute contraindications to
NOM they are used by some institutions as criteria for which to use prophylactic SAE in an
attempt to improve splenic salvage.[16] When employed in a prophylactic manner, the splenic
artery is embolized, which decreases the amount of blood flowing to the injured areas within
the spleen.[17] Splenic infarction is not inevitable since some perfusion occurs through
collateral circulation and splenic immune function is maintained even after embolization.[18]
Despite the potential benefit, prophylactic SAE has not been universally adopted. In a
multi-center retrospective study, Lee et al noted that there was a wide variation of SAE
utilization in Level 1 trauma centers, ranging from 5.1% to 33%.[19] This finding is not
unexpected considering that, in 2012, only 30% of trauma centers had a written guideline for
the management of splenic injury.[20] Despite these issues, NOM has been the standard of care
for more than 30 years and currently >85% of patients undergo an attempt at NOM.[2] In a
recent meta-analysis, the success rate of NOM is ~8.3% of all patients but the role of SAE in
improving NOM success rates is still unclear.[21]
Evidence for and against SAE in splenic injury
Recognizing that contrast extravasation on CT was a potential factor associated with NOM
failure, the surgeons at Shock Trauma in Maryland reported their initial experience with17
patients who were successfully managed with prophylactic SAE.[10] In 1995 they published a
larger series of patients with contrast extravasation on CT scan. All patients underwent
formal angiography and those with extravasation on angio underwent SAE.[22] In that paper, 87
of 90 (96.7%) patients had a negative angiography and were successfully managed with
observation alone. Successful NOM was noted in 56 of 60 (93.3%) patients with a positive
angio and subsequent SAE.[22] While these papers provided evidence that SAE could be helpful
in the management of BSI patients they did not provide evidence that one technique was better
than the other.
In one prospective multi-center observational study, Banerjee compared NOM splenic outcomes
in high-SAE utilization centers vs low-utilization centers. Despite similar patient
characteristics at presentation, the high SAE centers were noted to have a 50% lower rate of
failure of NOM (3.5 vs 7.6%, respectively).[20] Several additional studies have shown that
the addition of prophylactic SAE improves NOM success rates[4, 9, 23] but these are limited
by their lack of randomization.
While there is an abundance of data supporting SAE, there are several studies questioning the
role of embolization in splenic injury. Smith, et al reported their experience from 2000-2004
when 25% of their patients underwent SAE.[24] They noted a rather high overall NOM failure
rate (14%) but an even higher failure rate in the SAE group (27%). In a similar paper from
the same time period, Harbrecht and colleagues noted an insignificant difference in success
of NOM in the SAE group vs observation group (80% vs 77.8%, respectively).[25] Duchesne, et
al found that SAE was associated with increased rates of sepsis and ARDS when compared to a
group of patients who underwent immediate splenectomy, which raises concerns about the
technique itself and emphasizes the importance of patient selection.[7] The splenic injury
outcomes trial (SPOT) from 2014 also calls into question the utility of SAE.[26] In this
prospective observational multi-center trial, the investigators found no significant
difference in splenectomy rates with or without SAE (2.5% vs 3.5%).[26] They further expanded
on the resource utilization aspect of SAE and theorized that if embolization was employed in
the 15,000 patients with high grade splenic injury (based off current data) only 274 spleens
would be saved. Considering the cost and logistics of SAE, there may not be enough of a
societal benefit to justify widespread adoption of this technique.[26] Given these concerns,
the investigaors feel that the best way to answer this question is through a randomized
controlled trial.
Splenic Blush on CT
The first publications regarding the importance of splenic contrast blush after trauma were
published in the 1990's but these reports were sporadic and limited by small sample
sizes.[27] In addition, trauma surgeons were still grappling with what to do in patients with
a contrast blush and often erred on the side of some intervention (either splenectomy or
SAE).[28] In 2001, Omert and colleagues reviewed their series of 324 patients with splenic
injury. There was an 11% rate of splenic blush but they found that a blush was not associated
with NOM failure.[28] Post et al (2013) found that observation had a similar rate of
successful NOM when compared to SAE in low grade splenic injuries.[29] Conversely, Alarhayem
and his group in San Antonio found that blush on CT correlated with NOM failure even if no
contrast extravasation was noted on formal angiogram.[30] Most recently, Zarzaur explored the
effect of a contrast blush in 200 patients from 17 trauma centers.[31] While SAE was used in
59% of people, the splenectomy rate was similar between the SAE group (6.8%) and the
observation group (7.6%). This review demonstrated that a contrast blush is associated with a
high risk for failure but that SAE may not actually mitigate that risk.[31]
Our own institutional data has shown that the presence of a blush correlated with a higher
risk for NOM failure but this data is limited because of the retrospective nature. Our
institution rarely employs SAE for blunt splenic injury. For this reason, the investigators
feel that our institution is ideal to study the role of SAE in high-risk splenic injury.
Innovation
To date there has only been one randomized controlled trial comparing prophylactic SAE to
observation (SAE as needed) in high-grade splenic injuries.[16] While they showed no
difference in splenectomy rates between groups there was a significant difference in the rate
of unplanned embolization (29.2% in the observation group vs 1.5% in the prophylactic SAE
group). Another important detail is that this trial did not include patients with contrast
extravasation or blush on CT. Our proposed study will include patients with a splenic blush
because there is enough conflicting data in the literature to justify including this patient
population.
References:
1. Peitzman, A.B. and J.D. Richardson, Surgical treatment of injuries to the solid
abdominal organs: a 50-year perspective from the Journal of Trauma. J Trauma, 2010.
69(5): p. 1011-21.
2. Stassen, N.A., et al., Selective nonoperative management of blunt splenic injury: an
Eastern Association for the Surgery of Trauma practice management guideline. J Trauma
Acute Care Surg, 2012. 73(5 Suppl 4): p. S294-300.
3. Olthof, D.C., C.H. van der Vlies, and J.C. Goslings, Evidence-Based Management and
Controversies in Blunt Splenic Trauma. Curr Trauma Rep, 2017. 3(1): p. 32-37.
4. Bhullar, I.S., et al., Selective angiographic embolization of blunt splenic traumatic
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7. Duchesne, J.C., et al., Proximal splenic angioembolization does not improve outcomes in
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blush predicts failure of nonoperative management. J Trauma, 1995. 39(3): p. 507-12;
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Angioembolization? Am Surg, 2013. 73: p. 1089-1092.
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