Wounds and InjuriesNCT03231202
Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
A study testing Embolization in people with Wounds and Injuries, run by Oslo University Hospital at 12 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 12 sitesin 9 countries
- Study dates
- 1 Jul 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemodynamically compromised (not suitable for NOM)
- Needing transfusions
- CT shows evidence of significant contrast extravasation
- Other indications for laparotomy
- Prisoners
- Pregnant
Show all 9Show fewer
- >80 years old
- Penetrating injury
- Contraindication to iv contrast
Trial locations and contacts
12 sites in 9 countries.
12 sites in 9 countries
United States3 sites, 3 recruiting
- Not yet recruiting
Denver Health Medical Center
Denver, Colorado, 80204
Eric Campion
- Not yet recruiting
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Louis Alarcon
- Not yet recruiting
Harborview Medical Center
Seattle, Washington, 98104
Ron Maier
Josph Cushieri
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Royal London Hospital
London
Karim Brohi
- Not yet recruiting
Nottingham University Hospital
Nottingham
Adam Brooks
Australia1 site, 1 recruiting
- Not yet recruiting
Liverpool Hospital
Sydney
Scott D'Amours
Canada1 site, 1 recruiting
- Not yet recruiting
McGill University Health Centre
Montreal
Tarek Razek
Denmark1 site, 1 recruiting
- Not yet recruiting
Rigshospitalet
Copenhagen
Poul Svenningsen
Germany1 site, 1 recruiting
- Not yet recruiting
Kliniken der Stadt Köln
Cologne
Marc Maegele
Netherlands1 site, 1 recruiting
- Not yet recruiting
University Medical Center
Utrecht
Luke Leenen
Norway1 site, 1 recruiting
- Recruiting
Oslo Universtity Hospital
Oslo, 0450
iver Anders Gaski, MD, 90063971, iagaski@gmail.com
Knut Magne Kolstadbraten, 92212577 ext. 0047, KKOLSTAD@ous-hf.no
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska Institute
Stockholm
Lovisa Strømmer
Susanna Eriksson
About this study
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.
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.
Read the 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.
- Conditions
- Wounds and Injuries
- Being tested
- Embolization
- Keywords
- Non-operative management, Splenic Injury, Blunt, Splenic artery embolization, Trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolizationProcedure or surgery
Also called Splenic artery embolization (SAE)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (7)
Delayed bleeding episode
Incidence. Delayed bleeding episode is defined as hemodynamically unstable patient, CT verified contrast blush or drop in hemoglobin/hematocrit.
Measured: 6-12 weeks
All cause and spleen related mortality
Incidence
Measured: 6-12 weeks
All cause and spleen related failure of NOM
Incidence
Measured: 6-12 weeks
Pseudoaneurysms (PSA)
Incidence
Measured: 6-12 weeks
Symptomatic thromboembolic events
Incidence
Measured: 6-12 weeks
Other spleen related complications
Incidence
Measured: 6-12 weeks
Angiography related complications
Incidence
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Gaarder, Oslo University Hospital
- Investigators
- Christine Gaarder, MD, PhD, Principal investigator, Head, Department of Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231202
- Sponsor's protocol ID
- 2016/15608
- Other IDs
- 2016
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23114484Velmahos 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.
PubMed 20479344Davis 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.
PubMed 9637156Schurr 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.
PubMed 7473916McIntyre 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.
PubMed 15967903Sclafani 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.
PubMed 1887032Miller 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.
PubMed 24655852Bhullar 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.
PubMed 22673236Schimmer 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.
PubMed 26772452Haan 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.
PubMed 15761342Skattum 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.
PubMed 20673894Peitzman 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.
PubMed 16038813Cirocchi 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.
PubMed 24004931Zarzaur 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.
PubMed 19509611Clancy 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.
PubMed 22410104
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03231202
- Acronym / sponsor ID
- 2016/15608
- Conditions
- Wounds and Injuries
- Keywords
- Non-operative management, Splenic Injury, Blunt, Splenic artery embolization, Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Procedure: EmbolizationThe 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. |
| 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. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Hemodynamically compromised (not suitable for NOM)
- Needing transfusions
- CT shows evidence of significant contrast extravasation
- Other indications for laparotomy
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbolizationAlso: Splenic artery embolization (SAE)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. | Procedure or surgery | Embolization |
Primary outcome
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 secondary outcomes
Delayed bleeding episode
Time frame: 6-12 weeks
All cause and spleen related mortality
Time frame: 6-12 weeks
All cause and spleen related failure of NOM
Time frame: 6-12 weeks
Pseudoaneurysms (PSA)
Time frame: 6-12 weeks
Symptomatic thromboembolic events
Time frame: 6-12 weeks
Other spleen related complications
Time frame: 6-12 weeks
Angiography related complications
Time frame: 6-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Results publication: PubMed 23114484Stassen 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.
- Results publication: PubMed 20479344Velmahos 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.
- Results publication: PubMed 9637156Davis 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.
- Results publication: PubMed 7473916Schurr 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.
- Results publication: PubMed 15967903McIntyre 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.
- Results publication: PubMed 1887032Sclafani 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.
- Results publication: PubMed 24655852Miller 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.
- Results publication: PubMed 22673236Bhullar 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.
- Results publication: PubMed 26772452Schimmer 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.
- Results publication: PubMed 15761342Haan 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.
- Results publication: PubMed 20673894Skattum 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.
- Results publication: PubMed 16038813Peitzman 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.
- Individual participant dataSharing planned: No
Related trials for Wounds and Injuries
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Gaarder, MD, PhD principal investigator
Head, Department of Traumatology
12 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization in people with Wounds and Injuries, run by Oslo University Hospital at 12 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom, Australia, Canada, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact iver Anders Gaski, MD (90063971 ext. 0047, iagaski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of NOM (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231202, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.