Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT03231202
Status:
UNKNOWN
Last Update Posted:
2017-07-27
First Post:
2017-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of NOM', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Delayed bleeding episode', 'timeFrame': '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', 'timeFrame': '6-12 weeks', 'description': 'Incidence'}, {'measure': 'All cause and spleen related failure of NOM', 'timeFrame': '6-12 weeks', 'description': 'Incidence'}, {'measure': 'Pseudoaneurysms (PSA)', 'timeFrame': '6-12 weeks', 'description': 'Incidence'}, {'measure': 'Symptomatic thromboembolic events', 'timeFrame': '6-12 weeks', 'description': 'Incidence'}, {'measure': 'Other spleen related complications', 'timeFrame': '6-12 weeks', 'description': 'Incidence'}, {'measure': 'Angiography related complications', 'timeFrame': '6-12 weeks', 'description': 'Incidence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-operative management', 'Splenic Injury', 'Blunt', 'Splenic artery embolization', 'Trauma'], 'conditions': ['Wounds and Injuries']}, 'referencesModule': {'references': [{'pmid': '23114484', 'type': 'RESULT', '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': '20479344', 'type': 'RESULT', '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': '9637156', 'type': 'RESULT', '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': '7473916', 'type': 'RESULT', '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': '15967903', 'type': 'RESULT', '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': '1887032', 'type': 'RESULT', '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': '24655852', 'type': 'RESULT', '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': '22673236', 'type': 'RESULT', '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': '26772452', 'type': 'RESULT', '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': '15761342', 'type': 'RESULT', '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': '20673894', 'type': 'RESULT', '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': '16038813', 'type': 'RESULT', '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': '24004931', 'type': 'RESULT', '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': '19509611', 'type': 'RESULT', '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': '22410104', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCONTROL 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).\n\nINTERVENTION The intervention arm will perform SAE as a central embolization of the splenic artery.\n\nAdditional peripheral embolization is left to the discretion of the interventional radiologist.\n\nEach 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* blunt splenic injury OIS grade 4 or 5\n* Adult trauma patients (according to local definitions)\n* Present hemodynamically normal as judged by the responsible trauma consultant surgeon and eligible for NOM\n* Randomised within 48 hours of injury\n* Written informed consent is obtained\n\nExclusion Criteria:\n\n* Hemodynamically compromised (not suitable for NOM)\n* Needing transfusions\n* CT shows evidence of significant contrast extravasation\n* Other indications for laparotomy\n* Prisoners\n* Pregnant\n* \\>80 years old\n* Penetrating injury\n* Contraindication to iv contrast'}, 'identificationModule': {'nctId': 'NCT03231202', 'briefTitle': 'Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '2016/15608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Embolization', 'description': 'The intervention arm will perform SAE as a central embolization of the splenic artery.\n\nAdditional peripheral embolization is left to the discretion of the interventional radiologist.\n\nThe study does not interfere with local diagnostic work-up and treatment protocols.', 'interventionNames': ['Procedure: Embolization']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', '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.'}], 'interventions': [{'name': 'Embolization', 'type': 'PROCEDURE', 'otherNames': ['Splenic artery embolization (SAE)'], 'description': 'The intervention arm will perform SAE as a central embolization of the splenic artery.\n\nAdditional peripheral embolization is left to the discretion of the interventional radiologist.', 'armGroupLabels': ['Embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Campion', 'role': 'CONTACT'}], 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louis Alarcon', 'role': 'CONTACT'}], 'facility': 'University of Pittsburgh School of Medicine', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ron Maier', 'role': 'CONTACT'}, {'name': 'Josph Cushieri', 'role': 'CONTACT'}], 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Sydney', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': "Scott D'Amours", 'role': 'CONTACT'}], 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Montreal', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Tarek Razek', 'role': 'CONTACT'}], 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Copenhagen', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Poul Svenningsen', 'role': 'CONTACT'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Cologne', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marc Maegele', 'role': 'CONTACT'}], 'facility': 'Kliniken der Stadt Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Utrecht', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Luke Leenen', 'role': 'CONTACT'}], 'facility': 'University Medical Center', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '0450', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'iver Anders Gaski, MD', 'role': 'CONTACT', 'email': 'iagaski@gmail.com', 'phone': '90063971'}, {'name': 'Knut Magne Kolstadbraten', 'role': 'CONTACT', 'email': 'KKOLSTAD@ous-hf.no', 'phone': '92212577', 'phoneExt': '0047'}], 'facility': 'Oslo Universtity Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Stockholm', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Lovisa Strømmer', 'role': 'CONTACT'}, {'name': 'Susanna Eriksson', 'role': 'CONTACT'}], 'facility': 'Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Karim Brohi', 'role': 'CONTACT'}], 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Nottingham', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Adam Brooks', 'role': 'CONTACT'}], 'facility': 'Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'iver Anders Gaski, MD', 'role': 'CONTACT', 'email': 'iagaski@gmail.com', 'phone': '90063971', 'phoneExt': '0047'}, {'name': 'Christine Gaarder, MD, PhD', 'role': 'CONTACT', 'email': 'tinagaar@onliine.no', 'phone': '41318992', 'phoneExt': '0047'}], 'overallOfficials': [{'name': 'Christine Gaarder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head, Department of Traumatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Department of Traumatology', 'investigatorFullName': 'Christine Gaarder', 'investigatorAffiliation': 'Oslo University Hospital'}}}}