Splenic InjuryNCT01965548
Treatment of Splenic Trauma: a Retrospective Cohort Study
An observational study of Splenic Injury, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most frequent source of bleeding in the abdomen. Historically, splenectomy was the treatment of choice for splenic bleeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Splenic Injury
- What is being tested?
- Treatment of splenic injury
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2014to Oct 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a traumatic splenic injury admitted at University Hospital North Norway Tromsø
Who may be able to join
- All patients admitted at UNN Tromsø in the period of 01.01.2000 - 31.12.2013 and with the discharge diagnosis S36.0 Splenic injury (ICD-10)
Who cannot join
- no injury/coding error
- iatrogenic injury
- transfer >7 days after injury
- >10 days between injury and first hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most frequent source of bleeding in the abdomen.
Historically, splenectomy was the treatment of choice for splenic bleeding. For exsanguinating patients, open splenectomy is still the proper choice of treatment if the spleen is a significant source of bleeding. However, for hemodynamic stable patients with splenic injury, non-operative management (NOM) is an alternative, assuming they have no other indication for surgery (peritonitis).
Read more
Non-operative management includes observation and/or splenic artery embolisation (SAE), but the indications for observation and SAE varies between trauma centers. The greatest advantage of NOM is the preservation of splenic function.
In the investigators hospital splenic artery embolisation was introduced in 2007. The investigators want to describe the treatment of splenic injuries in their hospital, to see if the number of splenectomies has been recduced after 2007, and to see if SAE has also been used in transferred trauma patients.
- Conditions
- Splenic Injury
- Being tested
- Treatment of splenic injury
- Keywords
- spleen, injury, patient transfer, splenectomy, embolization, theurapeutic
- 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.
Treatment of splenic injuryProcedure or surgery
There are four possible treatments of splenic injury in this study:
- splenectomy
- splenic artery embolisation
- non-operative management
- any combination of the three treatments mentioned
| Study group | Role | What they receive |
|---|---|---|
| Splenic injury | All patients admitted at the University Hospital North Norway Tromsø with a splenic injury following trauma, are included in the study. Receives: Procedure: Treatment of splenic injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of splenic trauma treatment
There are three different treatments of splenic trauma treatment, resulting in four different treatments:
- splenectomy
- splenic artery embolization
- non-operative management
- any combination of the three treatments
Measured: 0-7 days
Secondary outcomes (4)
Mortality
Measured: 30 days
Length of hospital stay
Measured: 1 - 90 days
Length of stay in the intensive care unit
Measured: 0 - 90 days
Emergency procedures
Emergency procedures includes:
- Chest tube insertion
- Hemostatic surgery in the abdomen
- Hemostatic surgery in the pelvis with packing
- Thoracotomy
- Primary stabilization of fractures (external fixation)
- Endotracheal intubation
Measured: 0 - 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Splenic InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trond Dehli, PhD, Principal investigator, University Hospital og North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965548
- Sponsor's protocol ID
- Miltstudie1
- Status last verified
- Dec 2015
- First submitted
- 15 Oct 2013
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dehli T, Bagenholm A, Trasti NC, Monsen SA, Bartnes K. The treatment of spleen injuries: a retrospective study. Scand J Trauma Resusc Emerg Med. 2015 Oct 29;23:85. doi: 10.1186/s13049-015-0163-6.
PubMed 26514334
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Splenic Trauma: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT01965548
- Acronym / sponsor ID
- Miltstudie1
- Conditions
- Splenic Injury
- Keywords
- spleen, injury, patient transfer, splenectomy, embolization, theurapeutic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Oct 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.
In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most frequent source of bleeding in the abdomen.
Historically, splenectomy was the treatment of choice for splenic bleeding. For exsanguinating patients, open splenectomy is still the proper choice of treatment if the spleen is a significant source of bleeding. However, for hemodynamic stable patients with splenic injury, non-operative management (NOM) is an alternative, assuming they have no other indication for surgery (peritonitis).
Non-operative management includes observation and/or splenic artery embolisation (SAE), but the indications for observation and SAE varies between trauma centers. The greatest advantage of NOM is the preservation of splenic function.
In the investigators hospital splenic artery embolisation was introduced in 2007. The investigators want to describe the treatment of splenic injuries in their hospital, to see if the number of splenectomies has been recduced after 2007, and to see if SAE has also been used in transferred trauma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Splenic injury | – | Procedure: Treatment of splenic injuryAll patients admitted at the University Hospital North Norway Tromsø with a splenic injury following trauma, are included in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a traumatic splenic injury admitted at University Hospital North Norway Tromsø
Key inclusion criteria (1 listed)
- All patients admitted at UNN Tromsø in the period of 01.01.2000 - 31.12.2013 and with the discharge diagnosis S36.0 Splenic injury (ICD-10)
Key exclusion criteria (4 listed)
- no injury/coding error
- iatrogenic injury
- transfer >7 days after injury
- >10 days between injury and first hospital admission
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 |
|---|---|---|
| Treatment of splenic injuryThere are four possible treatments of splenic injury in this study: * splenectomy * splenic artery embolisation * non-operative management * any combination of the three treatments mentioned | Procedure or surgery | Splenic injury |
Primary outcome
type of splenic trauma treatment
Time frame: 0-7 days
There are three different treatments of splenic trauma treatment, resulting in four different treatments: * splenectomy * splenic artery embolization * non-operative management * any combination of the three treatments
4 secondary outcomes
Mortality
Time frame: 30 days
Length of hospital stay
Time frame: 1 - 90 days
Length of stay in the intensive care unit
Time frame: 0 - 90 days
Emergency procedures
Time frame: 0 - 7 days
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 11 Jan 2016.
- Derived from this study: PubMed 26514334Dehli T, Bagenholm A, Trasti NC, Monsen SA, Bartnes K. The treatment of spleen injuries: a retrospective study. Scand J Trauma Resusc Emerg Med. 2015 Oct 29;23:85. doi: 10.1186/s13049-015-0163-6.
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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.
Trond Dehli, PhD principal investigator
University Hospital og North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splenic Injury, run by University Hospital of North Norway at 1 site in Norway.
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 1 inclusion and 4 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 11 Jan 2016. 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 Norway. 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?
type of splenic trauma treatment (time frame: 0-7 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 NCT01965548, which also lists 1 linked publication.
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 11 Jan 2016.