Treatment of Splenic Trauma: a Retrospective Cohort Study

NCT ID: NCT01965548

Last Updated: 2016-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Splenic Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Splenic injury

All patients admitted at the University Hospital North Norway Tromsø with a splenic injury following trauma, are included in the study.

Treatment of splenic injury

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Trond Dehli, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital og North Norway

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital North Norway Tromsø

Tromsø, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26514334 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Miltstudie1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pre-Hospital Use of Plasma for Traumatic Hemorrhage
NCT02303964 WITHDRAWN PHASE2/PHASE3
Transfusion HeAd NecK Surgery
NCT03910816 COMPLETED