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

July 25, 2017 updated by: Christine Gaarder, Oslo University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
      • Sydney, Australia
        • Not yet recruiting
        • Liverpool Hospital
        • Contact:
          • Scott D'Amours
  • Canada
      • Montreal, Canada
        • Not yet recruiting
        • McGill University Health Centre
        • Contact:
          • Tarek Razek
  • Denmark
      • Copenhagen, Denmark
        • Not yet recruiting
        • Rigshospitalet
        • Contact:
          • Poul Svenningsen
  • Germany
      • Cologne, Germany
        • Not yet recruiting
        • Kliniken der Stadt Köln
        • Contact:
          • Marc Maegele
  • Netherlands
      • Utrecht, Netherlands
        • Not yet recruiting
        • University Medical Center
        • Contact:
          • Luke Leenen
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • Oslo Universtity Hospital
        • Contact:
        • Contact:
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinska Institute
        • Contact:
          • Lovisa Strømmer
        • Contact:
          • Susanna Eriksson
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Royal London Hospital
        • Contact:
          • Karim Brohi
      • Nottingham, United Kingdom
        • Not yet recruiting
        • Nottingham University Hospital
        • Contact:
          • Adam Brooks
  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Not yet recruiting
        • Denver Health Medical Center
        • Contact:
          • Eric Campion
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh School of Medicine
        • Contact:
          • Louis Alarcon
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • Harborview Medical Center
        • Contact:
          • Ron Maier
        • Contact:
          • Josph Cushieri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6-12 weeks
All cause and spleen related mortality
Time Frame: 6-12 weeks
Incidence
6-12 weeks
All cause and spleen related failure of NOM
Time Frame: 6-12 weeks
Incidence
6-12 weeks
Pseudoaneurysms (PSA)
Time Frame: 6-12 weeks
Incidence
6-12 weeks
Symptomatic thromboembolic events
Time Frame: 6-12 weeks
Incidence
6-12 weeks
Other spleen related complications
Time Frame: 6-12 weeks
Incidence
6-12 weeks
Angiography related complications
Time Frame: 6-12 weeks
Incidence
6-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Gaarder, MD, PhD, Head, Department of Traumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/15608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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