Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)

University of Oslo (UIO)

Status: Unknown

Conditions: Wounds and Injuries

Treatments: Procedure: Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03231202

2016/15608

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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
• Pregnant
• >80 years old
• Penetrating injury
• Contraindication to iv contrast

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Embolization

Experimental group

Description:

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.

Treatment:

Procedure: Embolization

Observation

No Intervention group

Description:

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.