<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03231202</url>
  </required_header>
  <id_info>
    <org_study_id>2016/15608</org_study_id>
    <nct_id>NCT03231202</nct_id>
  </id_info>
  <brief_title>Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to compare the failure rate due to splenic bleeding between the&#xD;
      patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative&#xD;
      management (NOM) and the patients not undergoing SAE. We hypothesize that the use of&#xD;
      pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomised controlled study will follow the clinical course of hemodynamically normal&#xD;
      trauma patients with Organ Injury Scale (OIS) grade 4 or 5 blunt splenic injuries, undergoing&#xD;
      SAE or observation only until day 7 post injury. Only hemodynamically normal patients will be&#xD;
      considered for enrolment into the study, and written informed consent from the patient is&#xD;
      required.&#xD;
&#xD;
      CONTROL The control arm in this randomized controlled trial will include only NOM patients&#xD;
      diagnosed with splenic injuries OIS grade 4 or 5 and suitable for observation alone, and will&#xD;
      comprise clinical observation according to local routines and protocols. The patients will be&#xD;
      observed with special focus on delayed bleeding and failure of NOM. A contrast enhanced US or&#xD;
      CT scan with arterial phase will be performed on day 3-5 to exclude PSA. On day 7, the&#xD;
      decision to perform SAE, splenectomy or continue NOM is left to the discretion of each&#xD;
      participating institution, and registered in the case report form (CRF).&#xD;
&#xD;
      INTERVENTION The intervention arm will perform SAE as a central embolization of the splenic&#xD;
      artery.&#xD;
&#xD;
      Additional peripheral embolization is left to the discretion of the interventional&#xD;
      radiologist.&#xD;
&#xD;
      Each institution decides whether patients in the SAE group are to undergo immunization or&#xD;
      not. The study does not interfere with local diagnostic work-up and treatment protocols.&#xD;
&#xD;
      We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and&#xD;
      increase the success rate of NOM leading to fewer splenectomies in this group of patients&#xD;
      without concomitant increased complication rates. Additionally, we want to explore the&#xD;
      effects of pre-emptive SAE vs observation alone on all cause failure rate, operative&#xD;
      procedures, repeat angiography rate, complications, critical care stay, and mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Failure of NOM</measure>
    <time_frame>7 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delayed bleeding episode</measure>
    <time_frame>6-12 weeks</time_frame>
    <description>Incidence. Delayed bleeding episode is defined as hemodynamically unstable patient, CT verified contrast blush or drop in hemoglobin/hematocrit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause and spleen related mortality</measure>
    <time_frame>6-12 weeks</time_frame>
    <description>Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause and spleen related failure of NOM</measure>
    <time_frame>6-12 weeks</time_frame>
    <description>Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pseudoaneurysms (PSA)</measure>
    <time_frame>6-12 weeks</time_frame>
    <description>Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic thromboembolic events</measure>
    <time_frame>6-12 weeks</time_frame>
    <description>Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other spleen related complications</measure>
    <time_frame>6-12 weeks</time_frame>
    <description>Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiography related complications</measure>
    <time_frame>6-12 weeks</time_frame>
    <description>Incidence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>Embolization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm will perform SAE as a central embolization of the splenic artery.&#xD;
Additional peripheral embolization is left to the discretion of the interventional radiologist.&#xD;
The study does not interfere with local diagnostic work-up and treatment protocols.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Embolization</intervention_name>
    <description>The intervention arm will perform SAE as a central embolization of the splenic artery.&#xD;
Additional peripheral embolization is left to the discretion of the interventional radiologist.</description>
    <arm_group_label>Embolization</arm_group_label>
    <other_name>Splenic artery embolization (SAE)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  blunt splenic injury OIS grade 4 or 5&#xD;
&#xD;
          -  Adult trauma patients (according to local definitions)&#xD;
&#xD;
          -  Present hemodynamically normal as judged by the responsible trauma consultant surgeon&#xD;
             and eligible for NOM&#xD;
&#xD;
          -  Randomised within 48 hours of injury&#xD;
&#xD;
          -  Written informed consent is obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamically compromised (not suitable for NOM)&#xD;
&#xD;
          -  Needing transfusions&#xD;
&#xD;
          -  CT shows evidence of significant contrast extravasation&#xD;
&#xD;
          -  Other indications for laparotomy&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  &gt;80 years old&#xD;
&#xD;
          -  Penetrating injury&#xD;
&#xD;
          -  Contraindication to iv contrast&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Gaarder, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head, Department of Traumatology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>iver Anders Gaski, MD</last_name>
    <phone>90063971</phone>
    <phone_ext>0047</phone_ext>
    <email>iagaski@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christine Gaarder, MD, PhD</last_name>
    <phone>41318992</phone>
    <phone_ext>0047</phone_ext>
    <email>tinagaar@onliine.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Denver Health Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eric Campion</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh School of Medicine</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Louis Alarcon</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ron Maier</last_name>
    </contact>
    <contact_backup>
      <last_name>Josph Cushieri</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Scott D'Amours</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tarek Razek</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Poul Svenningsen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kliniken der Stadt Köln</name>
      <address>
        <city>Cologne</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marc Maegele</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Luke Leenen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oslo Universtity Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>iver Anders Gaski, MD</last_name>
      <phone>90063971</phone>
      <email>iagaski@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Knut Magne Kolstadbraten</last_name>
      <phone>92212577</phone>
      <phone_ext>0047</phone_ext>
      <email>KKOLSTAD@ous-hf.no</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Karolinska Institute</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lovisa Strømmer</last_name>
    </contact>
    <contact_backup>
      <last_name>Susanna Eriksson</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Royal London Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Karim Brohi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospital</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Adam Brooks</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Stassen NA, Bhullar I, Cheng JD, Crandall ML, Friese RS, Guillamondegui OD, Jawa RS, Maung AA, Rohs TJ Jr, Sangosanya A, Schuster KM, Seamon MJ, Tchorz KM, Zarzuar BL, Kerwin AJ; Eastern Association for the Surgery of Trauma. Selective nonoperative management of blunt splenic injury: an Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S294-300. doi: 10.1097/TA.0b013e3182702afc.</citation>
    <PMID>23114484</PMID>
  </results_reference>
  <results_reference>
    <citation>Velmahos GC, Zacharias N, Emhoff TA, Feeney JM, Hurst JM, Crookes BA, Harrington DT, Gregg SC, Brotman S, Burke PA, Davis KA, Gupta R, Winchell RJ, Desjardins S, Alouidor R, Gross RI, Rosenblatt MS, Schulz JT, Chang Y. Management of the most severely injured spleen: a multicenter study of the Research Consortium of New England Centers for Trauma (ReCONECT). Arch Surg. 2010 May;145(5):456-60. doi: 10.1001/archsurg.2010.58.</citation>
    <PMID>20479344</PMID>
  </results_reference>
  <results_reference>
    <citation>Davis KA, Fabian TC, Croce MA, Gavant ML, Flick PA, Minard G, Kudsk KA, Pritchard FE. Improved success in nonoperative management of blunt splenic injuries: embolization of splenic artery pseudoaneurysms. J Trauma. 1998 Jun;44(6):1008-13; discussion 1013-5. doi: 10.1097/00005373-199806000-00013.</citation>
    <PMID>9637156</PMID>
  </results_reference>
  <results_reference>
    <citation>Schurr MJ, Fabian TC, Gavant M, Croce MA, Kudsk KA, Minard G, Woodman G, Pritchard FE. Management of blunt splenic trauma: computed tomographic contrast blush predicts failure of nonoperative management. J Trauma. 1995 Sep;39(3):507-12; discussion 512-3. doi: 10.1097/00005373-199509000-00018.</citation>
    <PMID>7473916</PMID>
  </results_reference>
  <results_reference>
    <citation>McIntyre LK, Schiff M, Jurkovich GJ. Failure of nonoperative management of splenic injuries: causes and consequences. Arch Surg. 2005 Jun;140(6):563-8; discussion 568-9. doi: 10.1001/archsurg.140.6.563.</citation>
    <PMID>15967903</PMID>
  </results_reference>
  <results_reference>
    <citation>Sclafani SJ, Weisberg A, Scalea TM, Phillips TF, Duncan AO. Blunt splenic injuries: nonsurgical treatment with CT, arteriography, and transcatheter arterial embolization of the splenic artery. Radiology. 1991 Oct;181(1):189-96. doi: 10.1148/radiology.181.1.1887032.</citation>
    <PMID>1887032</PMID>
  </results_reference>
  <results_reference>
    <citation>Miller PR, Chang MC, Hoth JJ, Mowery NT, Hildreth AN, Martin RS, Holmes JH, Meredith JW, Requarth JA. Prospective trial of angiography and embolization for all grade III to V blunt splenic injuries: nonoperative management success rate is significantly improved. J Am Coll Surg. 2014 Apr;218(4):644-8. doi: 10.1016/j.jamcollsurg.2014.01.040. Epub 2014 Jan 28.</citation>
    <PMID>24655852</PMID>
  </results_reference>
  <results_reference>
    <citation>Bhullar IS, Frykberg ER, Siragusa D, Chesire D, Paul J, Tepas JJ 3rd, Kerwin AJ. Selective angiographic embolization of blunt splenic traumatic injuries in adults decreases failure rate of nonoperative management. J Trauma Acute Care Surg. 2012 May;72(5):1127-34. doi: 10.1097/TA.0b013e3182569849.</citation>
    <PMID>22673236</PMID>
  </results_reference>
  <results_reference>
    <citation>Schimmer JA, van der Steeg AF, Zuidema WP. Splenic function after angioembolization for splenic trauma in children and adults: A systematic review. Injury. 2016 Mar;47(3):525-30. doi: 10.1016/j.injury.2015.10.047. Epub 2015 Nov 19.</citation>
    <PMID>26772452</PMID>
  </results_reference>
  <results_reference>
    <citation>Haan JM, Bochicchio GV, Kramer N, Scalea TM. Nonoperative management of blunt splenic injury: a 5-year experience. J Trauma. 2005 Mar;58(3):492-8. doi: 10.1097/01.ta.0000154575.49388.74.</citation>
    <PMID>15761342</PMID>
  </results_reference>
  <results_reference>
    <citation>Skattum J, Titze TL, Dormagen JB, Aaberge IS, Bechensteen AG, Gaarder PI, Gaarder C, Heier HE, Naess PA. Preserved splenic function after angioembolisation of high grade injury. Injury. 2012 Jan;43(1):62-6. doi: 10.1016/j.injury.2010.06.028. Epub 2010 Jul 31.</citation>
    <PMID>20673894</PMID>
  </results_reference>
  <results_reference>
    <citation>Peitzman AB, Harbrecht BG, Rivera L, Heil B; Eastern Association for the Surgery of Trauma Multiinstitutional Trials Workgroup. Failure of observation of blunt splenic injury in adults: variability in practice and adverse consequences. J Am Coll Surg. 2005 Aug;201(2):179-87. doi: 10.1016/j.jamcollsurg.2005.03.037.</citation>
    <PMID>16038813</PMID>
  </results_reference>
  <results_reference>
    <citation>Cirocchi R, Boselli C, Corsi A, Farinella E, Listorti C, Trastulli S, Renzi C, Desiderio J, Santoro A, Cagini L, Parisi A, Redler A, Noya G, Fingerhut A. Is non-operative management safe and effective for all splenic blunt trauma? A systematic review. Crit Care. 2013 Sep 3;17(5):R185. doi: 10.1186/cc12868.</citation>
    <PMID>24004931</PMID>
  </results_reference>
  <results_reference>
    <citation>Zarzaur BL, Vashi S, Magnotti LJ, Croce MA, Fabian TC. The real risk of splenectomy after discharge home following nonoperative management of blunt splenic injury. J Trauma. 2009 Jun;66(6):1531-6; discussion 1536-8. doi: 10.1097/TA.0b013e3181a4ed11.</citation>
    <PMID>19509611</PMID>
  </results_reference>
  <results_reference>
    <citation>Clancy AA, Tiruta C, Ashman D, Ball CG, Kirkpatrick AW. The song remains the same although the instruments are changing: complications following selective non-operative management of blunt spleen trauma: a retrospective review of patients at a level I trauma centre from 1996 to 2007. J Trauma Manag Outcomes. 2012 Mar 13;6(1):4. doi: 10.1186/1752-2897-6-4.</citation>
    <PMID>22410104</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Christine Gaarder</investigator_full_name>
    <investigator_title>Head, Department of Traumatology</investigator_title>
  </responsible_party>
  <keyword>Non-operative management</keyword>
  <keyword>Splenic Injury</keyword>
  <keyword>Blunt</keyword>
  <keyword>Splenic artery embolization</keyword>
  <keyword>Trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03231202
org study id: 2016/15608
nct id: NCT03231202
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Failure of NOM
time frame: 7 days
description: 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.
measure: Delayed bleeding episode
time frame: 6-12 weeks
description: Incidence. Delayed bleeding episode is defined as hemodynamically unstable patient, CT verified contrast blush or drop in hemoglobin/hematocrit.
measure: All cause and spleen related mortality
time frame: 6-12 weeks
description: Incidence
measure: All cause and spleen related failure of NOM
time frame: 6-12 weeks
description: Incidence
measure: Pseudoaneurysms (PSA)
time frame: 6-12 weeks
description: Incidence
measure: Symptomatic thromboembolic events
time frame: 6-12 weeks
description: Incidence
measure: Other spleen related complications
time frame: 6-12 weeks
description: Incidence
measure: Angiography related complications
time frame: 6-12 weeks
description: Incidence
arm group label: Embolization
arm group type: Experimental
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.
arm group label: Observation
arm group type: No Intervention
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.
intervention type: Procedure
intervention name: Embolization
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.
arm group label: Embolization
other name: Splenic artery embolization (SAE)
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Christine Gaarder, MD, PhD
role: Principal Investigator
affiliation: Head, Department of Traumatology
last name: iver Anders Gaski, MD
phone: 90063971
phone ext: 0047
email: iagaski@gmail.com
last name: Christine Gaarder, MD, PhD
phone: 41318992
phone ext: 0047
email: tinagaar@onliine.no
facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
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status: Not yet recruiting
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contact backup: 
facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Australia
country: Canada
country: Denmark
country: Germany
country: Netherlands
country: Norway
country: Sweden
country: United Kingdom
country: United States
citation: Stassen NA, Bhullar I, Cheng JD, Crandall ML, Friese RS, Guillamondegui OD, Jawa RS, Maung AA, Rohs TJ Jr, Sangosanya A, Schuster KM, Seamon MJ, Tchorz KM, Zarzuar BL, Kerwin AJ; Eastern Association for the Surgery of Trauma. Selective nonoperative management of blunt splenic injury: an Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S294-300. doi: 10.1097/TA.0b013e3182702afc.
PMID: 23114484
citation: Velmahos GC, Zacharias N, Emhoff TA, Feeney JM, Hurst JM, Crookes BA, Harrington DT, Gregg SC, Brotman S, Burke PA, Davis KA, Gupta R, Winchell RJ, Desjardins S, Alouidor R, Gross RI, Rosenblatt MS, Schulz JT, Chang Y. Management of the most severely injured spleen: a multicenter study of the Research Consortium of New England Centers for Trauma (ReCONECT). Arch Surg. 2010 May;145(5):456-60. doi: 10.1001/archsurg.2010.58.
PMID: 20479344
citation: Davis KA, Fabian TC, Croce MA, Gavant ML, Flick PA, Minard G, Kudsk KA, Pritchard FE. Improved success in nonoperative management of blunt splenic injuries: embolization of splenic artery pseudoaneurysms. J Trauma. 1998 Jun;44(6):1008-13; discussion 1013-5. doi: 10.1097/00005373-199806000-00013.
PMID: 9637156
citation: Schurr MJ, Fabian TC, Gavant M, Croce MA, Kudsk KA, Minard G, Woodman G, Pritchard FE. Management of blunt splenic trauma: computed tomographic contrast blush predicts failure of nonoperative management. J Trauma. 1995 Sep;39(3):507-12; discussion 512-3. doi: 10.1097/00005373-199509000-00018.
PMID: 7473916
citation: McIntyre LK, Schiff M, Jurkovich GJ. Failure of nonoperative management of splenic injuries: causes and consequences. Arch Surg. 2005 Jun;140(6):563-8; discussion 568-9. doi: 10.1001/archsurg.140.6.563.
PMID: 15967903
citation: Sclafani SJ, Weisberg A, Scalea TM, Phillips TF, Duncan AO. Blunt splenic injuries: nonsurgical treatment with CT, arteriography, and transcatheter arterial embolization of the splenic artery. Radiology. 1991 Oct;181(1):189-96. doi: 10.1148/radiology.181.1.1887032.
PMID: 1887032
citation: Miller PR, Chang MC, Hoth JJ, Mowery NT, Hildreth AN, Martin RS, Holmes JH, Meredith JW, Requarth JA. Prospective trial of angiography and embolization for all grade III to V blunt splenic injuries: nonoperative management success rate is significantly improved. J Am Coll Surg. 2014 Apr;218(4):644-8. doi: 10.1016/j.jamcollsurg.2014.01.040. Epub 2014 Jan 28.
PMID: 24655852
citation: Bhullar IS, Frykberg ER, Siragusa D, Chesire D, Paul J, Tepas JJ 3rd, Kerwin AJ. Selective angiographic embolization of blunt splenic traumatic injuries in adults decreases failure rate of nonoperative management. J Trauma Acute Care Surg. 2012 May;72(5):1127-34. doi: 10.1097/TA.0b013e3182569849.
PMID: 22673236
citation: Schimmer JA, van der Steeg AF, Zuidema WP. Splenic function after angioembolization for splenic trauma in children and adults: A systematic review. Injury. 2016 Mar;47(3):525-30. doi: 10.1016/j.injury.2015.10.047. Epub 2015 Nov 19.
PMID: 26772452
citation: Haan JM, Bochicchio GV, Kramer N, Scalea TM. Nonoperative management of blunt splenic injury: a 5-year experience. J Trauma. 2005 Mar;58(3):492-8. doi: 10.1097/01.ta.0000154575.49388.74.
PMID: 15761342
citation: Skattum J, Titze TL, Dormagen JB, Aaberge IS, Bechensteen AG, Gaarder PI, Gaarder C, Heier HE, Naess PA. Preserved splenic function after angioembolisation of high grade injury. Injury. 2012 Jan;43(1):62-6. doi: 10.1016/j.injury.2010.06.028. Epub 2010 Jul 31.
PMID: 20673894
citation: Peitzman AB, Harbrecht BG, Rivera L, Heil B; Eastern Association for the Surgery of Trauma Multiinstitutional Trials Workgroup. Failure of observation of blunt splenic injury in adults: variability in practice and adverse consequences. J Am Coll Surg. 2005 Aug;201(2):179-87. doi: 10.1016/j.jamcollsurg.2005.03.037.
PMID: 16038813
citation: Cirocchi R, Boselli C, Corsi A, Farinella E, Listorti C, Trastulli S, Renzi C, Desiderio J, Santoro A, Cagini L, Parisi A, Redler A, Noya G, Fingerhut A. Is non-operative management safe and effective for all splenic blunt trauma? A systematic review. Crit Care. 2013 Sep 3;17(5):R185. doi: 10.1186/cc12868.
PMID: 24004931
citation: Zarzaur BL, Vashi S, Magnotti LJ, Croce MA, Fabian TC. The real risk of splenectomy after discharge home following nonoperative management of blunt splenic injury. J Trauma. 2009 Jun;66(6):1531-6; discussion 1536-8. doi: 10.1097/TA.0b013e3181a4ed11.
PMID: 19509611
citation: Clancy AA, Tiruta C, Ashman D, Ball CG, Kirkpatrick AW. The song remains the same although the instruments are changing: complications following selective non-operative management of blunt spleen trauma: a retrospective review of patients at a level I trauma centre from 1996 to 2007. J Trauma Manag Outcomes. 2012 Mar 13;6(1):4. doi: 10.1186/1752-2897-6-4.
PMID: 22410104
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Christine Gaarder
investigator title: Head, Department of Traumatology
mesh term: Wounds and Injuries
sharing ipd: No