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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wounds and Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Embolization

Intervention Type PROCEDURE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Splenic artery embolization (SAE)

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Christine Gaarder

Head, Department of Traumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Gaarder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head, Department of Traumatology

Locations

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