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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231202
Recruitment Status : Unknown
Verified July 2017 by Christine Gaarder, Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Christine Gaarder, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Procedure: Embolization Not Applicable

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.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Arm Intervention/treatment
Experimental: 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.

Procedure: 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.

Other Name: Splenic artery embolization (SAE)

No Intervention: 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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Delayed bleeding episode [ Time Frame: 6-12 weeks ]
    Incidence. Delayed bleeding episode is defined as hemodynamically unstable patient, CT verified contrast blush or drop in hemoglobin/hematocrit.

  2. All cause and spleen related mortality [ Time Frame: 6-12 weeks ]
    Incidence

  3. All cause and spleen related failure of NOM [ Time Frame: 6-12 weeks ]
    Incidence

  4. Pseudoaneurysms (PSA) [ Time Frame: 6-12 weeks ]
    Incidence

  5. Symptomatic thromboembolic events [ Time Frame: 6-12 weeks ]
    Incidence

  6. Other spleen related complications [ Time Frame: 6-12 weeks ]
    Incidence

  7. Angiography related complications [ Time Frame: 6-12 weeks ]
    Incidence



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231202


Contacts
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Contact: iver Anders Gaski, MD 90063971 ext 0047 iagaski@gmail.com
Contact: Christine Gaarder, MD, PhD 41318992 ext 0047 tinagaar@onliine.no

Locations
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United States, Colorado
Denver Health Medical Center Not yet recruiting
Denver, Colorado, United States, 80204
Contact: Eric Campion         
United States, Pennsylvania
University of Pittsburgh School of Medicine Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Louis Alarcon         
United States, Washington
Harborview Medical Center Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Ron Maier         
Contact: Josph Cushieri         
Australia
Liverpool Hospital Not yet recruiting
Sydney, Australia
Contact: Scott D'Amours         
Canada
McGill University Health Centre Not yet recruiting
Montreal, Canada
Contact: Tarek Razek         
Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Poul Svenningsen         
Germany
Kliniken der Stadt Köln Not yet recruiting
Cologne, Germany
Contact: Marc Maegele         
Netherlands
University Medical Center Not yet recruiting
Utrecht, Netherlands
Contact: Luke Leenen         
Norway
Oslo Universtity Hospital Recruiting
Oslo, Norway, 0450
Contact: iver Anders Gaski, MD    90063971    iagaski@gmail.com   
Contact: Knut Magne Kolstadbraten    92212577 ext 0047    KKOLSTAD@ous-hf.no   
Sweden
Karolinska Institute Not yet recruiting
Stockholm, Sweden
Contact: Lovisa Strømmer         
Contact: Susanna Eriksson         
United Kingdom
Royal London Hospital Not yet recruiting
London, United Kingdom
Contact: Karim Brohi         
Nottingham University Hospital Not yet recruiting
Nottingham, United Kingdom
Contact: Adam Brooks         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Christine Gaarder, MD, PhD Head, Department of Traumatology
Publications of Results:

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Responsible Party: Christine Gaarder, Head, Department of Traumatology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03231202    
Other Study ID Numbers: 2016/15608
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christine Gaarder, Oslo University Hospital:
Non-operative management
Splenic Injury
Blunt
Splenic artery embolization
Trauma
Additional relevant MeSH terms:
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Wounds and Injuries