Treatment of Splenic Trauma: a Retrospective Cohort Study

January 8, 2016 updated by: University Hospital of North Norway

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, 9038
        • University Hospital North Norway Tromsø

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with a traumatic splenic injury admitted at University Hospital North Norway Tromsø

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Splenic injury
All patients admitted at the University Hospital North Norway Tromsø with a splenic injury following trauma, are included in the study.
Procedure: Treatment of splenic injury

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30 days
Length of hospital stay
Time Frame: 1 - 90 days
1 - 90 days
Length of stay in the intensive care unit
Time Frame: 0 - 90 days
0 - 90 days
Emergency procedures
Time Frame: 0 - 7 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Investigators

  • Principal Investigator: Trond Dehli, PhD, University Hospital og North Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Miltstudie1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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