NCT03231202

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
9 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

July 5, 2017

Last Update Submit

July 25, 2017

Conditions

Wounds and Injuries

Keywords

Non-operative managementSplenic InjuryBluntSplenic artery embolizationTrauma

Outcome Measures

Primary Outcomes (1)

  • Failure of NOM

    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 Outcomes (7)

  • Delayed bleeding episode

    6-12 weeks

  • All cause and spleen related mortality

    6-12 weeks

  • All cause and spleen related failure of NOM

    6-12 weeks

  • Pseudoaneurysms (PSA)

    6-12 weeks

  • Symptomatic thromboembolic events

    6-12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Embolization

EXPERIMENTAL

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

Observation

NO INTERVENTION

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

EmbolizationPROCEDURE

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.

Also known as: Splenic artery embolization (SAE)
Embolization

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Denver Health Medical Center

Denver, Colorado, 80204, United States

NOT YET RECRUITING

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Harborview Medical Center

Seattle, Washington, 98104, United States

NOT YET RECRUITING

Liverpool Hospital

Sydney, Australia

NOT YET RECRUITING

McGill University Health Centre

Montreal, Canada

NOT YET RECRUITING

Rigshospitalet

Copenhagen, Denmark

NOT YET RECRUITING

Kliniken der Stadt Köln

Cologne, Germany

NOT YET RECRUITING

University Medical Center

Utrecht, Netherlands

NOT YET RECRUITING

Oslo Universtity Hospital

Oslo, 0450, Norway

RECRUITING

Karolinska Institute

Stockholm, Sweden

NOT YET RECRUITING

Royal London Hospital

London, United Kingdom

NOT YET RECRUITING

Nottingham University Hospital

Nottingham, United Kingdom

NOT YET RECRUITING

Related Publications (15)

  • 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: 23114484RESULT

  • 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: 20479344RESULT

  • 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: 9637156RESULT

  • 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: 7473916RESULT

  • 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: 15967903RESULT

  • 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: 1887032RESULT

  • 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: 24655852RESULT

  • 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: 22673236RESULT

  • 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: 26772452RESULT

  • 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: 15761342RESULT

  • 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: 20673894RESULT

  • 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: 16038813RESULT

  • 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: 24004931RESULT

  • 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: 19509611RESULT

  • 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: 22410104RESULT

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Embolization, Therapeutic

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Christine Gaarder, MD, PhD

    Head, Department of Traumatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

iver Anders Gaski, MD

CONTACT

90063971iagaski@gmail.com

Christine Gaarder, MD, PhD

CONTACT

41318992tinagaar@onliine.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Department of Traumatology

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 27, 2017

Study Start

July 1, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)NL(1)DK(1)US(3)AU(1)GB(2)CA(1)DE(1)NO(1)