Splenic Injury Clinical Trial
Official title:
Treatment of Splenic Trauma: a Retrospective Cohort Study
| Verified date | December 2015 |
| Source | University Hospital of North Norway |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway: Data Protection Authority |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - no injury/coding error - iatrogenic injury - transfer >7 days after injury - >10 days between injury and first hospital admission |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Norway | University Hospital North Norway Tromsø | Tromsø |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of North Norway |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
0-7 days | No |
| Secondary | Mortality | 30 days | No | |
| Secondary | Length of hospital stay | 1 - 90 days | No | |
| Secondary | Length of stay in the intensive care unit | 0 - 90 days | No | |
| Secondary | 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 |
0 - 7 days | No |