Splenic TraumaSplashNCT02021396
Benefit of Prophylactic Embolization of the Splenic Salvage
A study testing Embolization in people with Splenic Trauma, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of splenectomy Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Splenic Trauma
- 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
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jun 2018
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 and under 75 years
- hemodynamically stable patients (systolic BP ≥ 90 mm Hg and no hemorrhagic shock)
- Suffered a closed splenic trauma within the last 48 hours
- A high risk of splenectomy:
- Reaching spleen Moore grade 4 and 5 in the abdominal injected CT or
- Reaching spleen Moore 3 and at least one of the following characteristics:
Show all 10Show fewer
- Important Hemoperitoneum (when visible in the pelvic area).
- Severe associated impairment (NISS-New Injury Severity Score greater than or equal to 15)
- Patients volunteering to participate in the study, having signed the consent form or with the agreement of the family if the patient is not capable of giving consent; after adequate information and delivery of the patient and/or family information leaflet.
- covered by a social security scheme or beneficiary of such a plan.
Who cannot join
- Patients whose usual residence is outside the European Economic Community
- Patient with hemodynamic instability (systolic blood pressure <9 despite resuscitation maneuver)
- Patient with open splenic trauma
- Patient with surgical indication excluding the possibility of monitoring splenic trauma
- Patient with an indication for embolization of a body other than the spleen at the time of inclusion
- Patient with an indication for splenic embolization as a result of a post-traumatic vascular anomaly (active leakage of contrast agent, pseudoaneurysm or early splenic arteriovenous fistula).
Show all 17Show fewer
- Patients aged less than 18 years and ≥ 75 years
- Patients with a previous spleen disease (tumor, infection, vascular anomaly intrasplenically)
- Patient with trauma Moore grade 1 or 2
- Patient with trauma grade Moore 5 with total ischemia of the spleen
- Patients who underwent partial or total splenectomy before inclusion
- Patient having acquired or innate immune deficiency
- All indications not permitting the achievement of embolization
- Pregnant woman
- Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection.
- Patient currently participating in a clinical study or having participated in a clinical study in the month preceding the inclusion
- Patient with a condition or a history of mental or psychiatric disorder or any other factor limiting their ability to participate in an informed manner and to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Grenoble Alpes
Grenoble, Auvergne-Rhône-Alpes, 38000
About this study
Official title: Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.
The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of splenectomy
- Conditions
- Splenic Trauma
- Being tested
- Embolization
- Keywords
- splenic rescue; splenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolizationProcedure or surgery
this arm of the study was interventional (splenic artery embolization)
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Experimental | this arm of the study was interventional (embolization) with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180) read by 2 expert radiologists blinded to the study arm Receives: Procedure: Embolization |
| Surveillance | No intervention | this arm of the study was non-interventional (surveillance), with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180 ) read by 2 expert radiologists blinded to the study arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue rate
The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of a splenectomy. The primary endpoint is an immunocompetent spleen i.e. intact or treated by surgical methods for splenic preservation of at least 50% of splenic vascularized tissue in the event of secondary laparotomy or with necrosis of less than 50% by volume. This criterion will be validated by a review of the initial scans by a panel of two senior radiologists blinded to the study arm.
Measured: Splenic Rescue at 30 days
Secondary outcomes (2)
Mortality
Measured: At 1 and 6 months
Morbidity
Measured: at 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Splenic TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr Catherine ARVIEUX, Principal investigator, University Clinic of Digestive Surgery and Emergency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021396
- Sponsor's protocol ID
- DCIC 13 02
- Acronym
- Splash
- Status last verified
- Jul 2018
- First submitted
- 3 Dec 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Arnoletti JP, Karam J, Brodsky J. Early postoperative complications of splenectomy for hematologic disease. Am J Clin Oncol. 1999 Apr;22(2):114-8. doi: 10.1097/00000421-199904000-00002.
PubMed 10199442Requarth JA, D'Agostino RB Jr, Miller PR. Nonoperative management of adult blunt splenic injury with and without splenic artery embolotherapy: a meta-analysis. J Trauma. 2011 Oct;71(4):898-903; discussion 903. doi: 10.1097/TA.0b013e318227ea50.
PubMed 21986737Benoist S. [Median and long-term complications of splenectomy]. Ann Chir. 2000 May;125(4):317-24. doi: 10.1016/s0003-3944(00)00201-7. French.
PubMed 10900732Altamura M, Caradonna L, Amati L, Pellegrino NM, Urgesi G, Miniello S. Splenectomy and sepsis: the role of the spleen in the immune-mediated bacterial clearance. Immunopharmacol Immunotoxicol. 2001 May;23(2):153-61. doi: 10.1081/iph-100103856.
PubMed 11417844Kotsanas D, Al-Souffi MH, Waxman BP, King RW, Polkinghorne KR, Woolley IJ. Adherence to guidelines for prevention of postsplenectomy sepsis. Age and sex are risk factors: a five-year retrospective review. ANZ J Surg. 2006 Jul;76(7):542-7. doi: 10.1111/j.1445-2197.2006.03775.x.
PubMed 16813615Bain IM, Kirby RM. 10 year experience of splenic injury: an increasing place for conservative management after blunt trauma. Injury. 1998 Apr;29(3):177-82. doi: 10.1016/s0020-1383(97)00170-8.
PubMed 9709417Peitzman AB, Heil B, Rivera L, Federle MB, Harbrecht BG, Clancy KD, Croce M, Enderson BL, Morris JA, Shatz D, Meredith JW, Ochoa JB, Fakhry SM, Cushman JG, Minei JP, McCarthy M, Luchette FA, Townsend R, Tinkoff G, Block EF, Ross S, Frykberg ER, Bell RM, Davis F 3rd, Weireter L, Shapiro MB. Blunt splenic injury in adults: Multi-institutional Study of the Eastern Association for the Surgery of Trauma. J Trauma. 2000 Aug;49(2):177-87; discussion 187-9. doi: 10.1097/00005373-200008000-00002.
PubMed 10963527Haan JM, Biffl W, Knudson MM, Davis KA, Oka T, Majercik S, Dicker R, Marder S, Scalea TM; Western Trauma Association Multi-Institutional Trials Committee. Splenic embolization revisited: a multicenter review. J Trauma. 2004 Mar;56(3):542-7. doi: 10.1097/01.ta.0000114069.73054.45.
PubMed 15128125Liu PP, Lee WC, Cheng YF, Hsieh PM, Hsieh YM, Tan BL, Chen FC, Huang TC, Tung CC. Use of splenic artery embolization as an adjunct to nonsurgical management of blunt splenic injury. J Trauma. 2004 Apr;56(4):768-72; discussion 773. doi: 10.1097/01.ta.0000129646.14777.ff.
PubMed 15187739Gaarder C, Dormagen JB, Eken T, Skaga NO, Klow NE, Pillgram-Larsen J, Buanes T, Naess PA. Nonoperative management of splenic injuries: improved results with angioembolization. J Trauma. 2006 Jul;61(1):192-8. doi: 10.1097/01.ta.0000223466.62589.d9.
PubMed 16832270Sabe AA, Claridge JA, Rosenblum DI, Lie K, Malangoni MA. The effects of splenic artery embolization on nonoperative management of blunt splenic injury: a 16-year experience. J Trauma. 2009 Sep;67(3):565-72; discussion 571-2. doi: 10.1097/TA.0b013e3181b17010.
PubMed 19741401Ekeh AP, McCarthy MC, Woods RJ, Haley E. Complications arising from splenic embolization after blunt splenic trauma. Am J Surg. 2005 Mar;189(3):335-9. doi: 10.1016/j.amjsurg.2004.11.033.
PubMed 15792763Haan J, Bochicchio G, Kramer M, Scalea T. Air following splenic embolization: infection or incidental finding? Am Surg. 2003 Dec;69(12):1036-9; discussion 1039-40.
PubMed 14700287Bessoud B, Duchosal MA, Siegrist CA, Schlegel S, Doenz F, Calmes JM, Qanadli SD, Schnyder P, Denys A. Proximal splenic artery embolization for blunt splenic injury: clinical, immunologic, and ultrasound-Doppler follow-up. J Trauma. 2007 Jun;62(6):1481-6. doi: 10.1097/TA.0b013e318047dfb8.
PubMed 17563670Sugg SL, Gerndt SJ, Hamilton BJ, Francis IR, Taheri PA, Rodriguez JL. Pseudoaneurysms of the intraparenchymal splenic artery after blunt abdominal trauma: a complication of nonoperative therapy and its management. J Trauma. 1995 Sep;39(3):593-5. doi: 10.1097/00005373-199509000-00034.
PubMed 7473932
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.
- ClinicalTrials.gov ID
- NCT02021396
- Acronym / sponsor ID
- Splash / DCIC 13 02
- Conditions
- Splenic Trauma
- Keywords
- splenic rescue; splenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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 main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of splenectomy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Procedure: Embolizationthis arm of the study was interventional (embolization) with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180) read by 2 expert radiologists blinded to the study arm |
| Surveillance | No intervention | –this arm of the study was non-interventional (surveillance), with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180 ) read by 2 expert radiologists blinded to the study arm |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged over 18 and under 75 years
- hemodynamically stable patients (systolic BP ≥ 90 mm Hg and no hemorrhagic shock)
- Suffered a closed splenic trauma within the last 48 hours
- A high risk of splenectomy:
- Patients volunteering to participate in the study, having signed the consent form or with the agreement of the family if the patient is not capable of giving consent; after adequate information and delivery of the patient and/or family information leaflet.
Key exclusion criteria (17 listed)
- Patients whose usual residence is outside the European Economic Community
- Patient with hemodynamic instability (systolic blood pressure <9 despite resuscitation maneuver)
- Patient with open splenic trauma
- Patient with surgical indication excluding the possibility of monitoring splenic trauma
- Patient with an indication for embolization of a body other than the spleen at the time of inclusion
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 |
|---|---|---|
| Embolizationthis arm of the study was interventional (splenic artery embolization) | Procedure or surgery | Embolization |
Primary outcome
Rescue rate
Time frame: Splenic Rescue at 30 days
The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of a splenectomy. The primary endpoint is an immunocompetent spleen i.e. intact or treated by surgical methods for splenic preservation of at least 50% of splenic vascularized tissue in the event of secondary laparotomy or with necrosis of less than 50% by volume. This criterion will be validated by a review of the initial scans by a panel of two senior radiologists blinded to the study arm.
2 secondary outcomes
Mortality
Time frame: At 1 and 6 months
Morbidity
Time frame: at 1 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 10199442Arnoletti JP, Karam J, Brodsky J. Early postoperative complications of splenectomy for hematologic disease. Am J Clin Oncol. 1999 Apr;22(2):114-8. doi: 10.1097/00000421-199904000-00002.
- Background: PubMed 21986737Requarth JA, D'Agostino RB Jr, Miller PR. Nonoperative management of adult blunt splenic injury with and without splenic artery embolotherapy: a meta-analysis. J Trauma. 2011 Oct;71(4):898-903; discussion 903. doi: 10.1097/TA.0b013e318227ea50.
- Background: PubMed 10900732Benoist S. [Median and long-term complications of splenectomy]. Ann Chir. 2000 May;125(4):317-24. doi: 10.1016/s0003-3944(00)00201-7. French.
- Background: PubMed 11417844Altamura M, Caradonna L, Amati L, Pellegrino NM, Urgesi G, Miniello S. Splenectomy and sepsis: the role of the spleen in the immune-mediated bacterial clearance. Immunopharmacol Immunotoxicol. 2001 May;23(2):153-61. doi: 10.1081/iph-100103856.
- Background: PubMed 16813615Kotsanas D, Al-Souffi MH, Waxman BP, King RW, Polkinghorne KR, Woolley IJ. Adherence to guidelines for prevention of postsplenectomy sepsis. Age and sex are risk factors: a five-year retrospective review. ANZ J Surg. 2006 Jul;76(7):542-7. doi: 10.1111/j.1445-2197.2006.03775.x.
- Background: PubMed 9709417Bain IM, Kirby RM. 10 year experience of splenic injury: an increasing place for conservative management after blunt trauma. Injury. 1998 Apr;29(3):177-82. doi: 10.1016/s0020-1383(97)00170-8.
- Background: PubMed 10963527Peitzman AB, Heil B, Rivera L, Federle MB, Harbrecht BG, Clancy KD, Croce M, Enderson BL, Morris JA, Shatz D, Meredith JW, Ochoa JB, Fakhry SM, Cushman JG, Minei JP, McCarthy M, Luchette FA, Townsend R, Tinkoff G, Block EF, Ross S, Frykberg ER, Bell RM, Davis F 3rd, Weireter L, Shapiro MB. Blunt splenic injury in adults: Multi-institutional Study of the Eastern Association for the Surgery of Trauma. J Trauma. 2000 Aug;49(2):177-87; discussion 187-9. doi: 10.1097/00005373-200008000-00002.
- Background: PubMed 15128125Haan JM, Biffl W, Knudson MM, Davis KA, Oka T, Majercik S, Dicker R, Marder S, Scalea TM; Western Trauma Association Multi-Institutional Trials Committee. Splenic embolization revisited: a multicenter review. J Trauma. 2004 Mar;56(3):542-7. doi: 10.1097/01.ta.0000114069.73054.45.
- Background: PubMed 15187739Liu PP, Lee WC, Cheng YF, Hsieh PM, Hsieh YM, Tan BL, Chen FC, Huang TC, Tung CC. Use of splenic artery embolization as an adjunct to nonsurgical management of blunt splenic injury. J Trauma. 2004 Apr;56(4):768-72; discussion 773. doi: 10.1097/01.ta.0000129646.14777.ff.
- Background: PubMed 16832270Gaarder C, Dormagen JB, Eken T, Skaga NO, Klow NE, Pillgram-Larsen J, Buanes T, Naess PA. Nonoperative management of splenic injuries: improved results with angioembolization. J Trauma. 2006 Jul;61(1):192-8. doi: 10.1097/01.ta.0000223466.62589.d9.
- Background: PubMed 19741401Sabe AA, Claridge JA, Rosenblum DI, Lie K, Malangoni MA. The effects of splenic artery embolization on nonoperative management of blunt splenic injury: a 16-year experience. J Trauma. 2009 Sep;67(3):565-72; discussion 571-2. doi: 10.1097/TA.0b013e3181b17010.
- Background: PubMed 15792763Ekeh AP, McCarthy MC, Woods RJ, Haley E. Complications arising from splenic embolization after blunt splenic trauma. Am J Surg. 2005 Mar;189(3):335-9. doi: 10.1016/j.amjsurg.2004.11.033.
- Individual participant dataSharing planned: Undecided
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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.
Pr Catherine ARVIEUX principal investigator
University Clinic of Digestive Surgery and Emergency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization in people with Splenic Trauma, run by University Hospital, Grenoble at 1 site in France.
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 10 inclusion and 17 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: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rescue rate (time frame: Splenic Rescue at 30 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 NCT02021396, which also lists 48 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 26 Jul 2018.