Wounds and Injuries Clinical Trial
Official title:
A Multi-centre, Prospective, Randomized Controlled Study to Compare Outcomes of Non-operative Management (NOM) With and Without Splenic Arterial Embolization (SAE) in Hemodynamically Stable OIS Grade 4 and 5 Splenic Injuries.
The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative management (NOM) and the patients not undergoing SAE. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.
This randomised controlled study will follow the clinical course of hemodynamically normal
trauma patients with Organ Injury Scale (OIS) grade 4 or 5 blunt splenic injuries, undergoing
SAE or observation only until day 7 post injury. Only hemodynamically normal patients will be
considered for enrolment into the study, and written informed consent from the patient is
required.
CONTROL The control arm in this randomized controlled trial will include only NOM patients
diagnosed with splenic injuries OIS grade 4 or 5 and suitable for observation alone, and will
comprise clinical observation according to local routines and protocols. The patients will be
observed with special focus on delayed bleeding and failure of NOM. A contrast enhanced US or
CT scan with arterial phase will be performed on day 3-5 to exclude PSA. On day 7, the
decision to perform SAE, splenectomy or continue NOM is left to the discretion of each
participating institution, and registered in the case report form (CRF).
INTERVENTION The intervention arm will perform SAE as a central embolization of the splenic
artery.
Additional peripheral embolization is left to the discretion of the interventional
radiologist.
Each institution decides whether patients in the SAE group are to undergo immunization or
not. The study does not interfere with local diagnostic work-up and treatment protocols.
We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and
increase the success rate of NOM leading to fewer splenectomies in this group of patients
without concomitant increased complication rates. Additionally, we want to explore the
effects of pre-emptive SAE vs observation alone on all cause failure rate, operative
procedures, repeat angiography rate, complications, critical care stay, and mortality.
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