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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 224
- Locations
- 12
- Primary Endpoint
- Failure of NOM
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •blunt splenic injury OIS grade 4 or 5
- •Adult trauma patients (according to local definitions)
- •Present hemodynamically normal as judged by the responsible trauma consultant surgeon and eligible for NOM
- •Randomised within 48 hours of injury
- •Written informed consent is obtained
Exclusion Criteria
- •Hemodynamically compromised (not suitable for NOM)
- •Needing transfusions
- •CT shows evidence of significant contrast extravasation
- •Other indications for laparotomy
- •Prisoners
- •>80 years old
- •Penetrating injury
- •Contraindication to iv contrast
Arms & Interventions
Embolization
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.
The study does not interfere with local diagnostic work-up and treatment protocols.
Intervention: Embolization (Procedure)
Observation
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.
Outcomes
Primary Outcomes
Failure of NOM
Time Frame: 7 days
The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive SAE as part of NOM and the patients not undergoing SAE. The primary endpoint is the proportion of subjects failing NOM due to spleen related bleeding within 7 days of injury. All analyses will be based on an intention to treat analysis.
Secondary Outcomes
- Other spleen related complications(6-12 weeks)
- Angiography related complications(6-12 weeks)
- All cause and spleen related failure of NOM(6-12 weeks)
- Delayed bleeding episode(6-12 weeks)
- Symptomatic thromboembolic events(6-12 weeks)
- Pseudoaneurysms (PSA)(6-12 weeks)
- All cause and spleen related mortality(6-12 weeks)
Investigators
Christine Gaarder
Head, Department of Traumatology
Oslo University Hospital