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Completed

NCT Number: NCT01965548

Treatment of Splenic Trauma: a Retrospective Cohort 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).

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.

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Key information

Conditions

Splenic Injury Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital North Norway Tromsø

Tromsø, 9038, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of splenic injury

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Mortality

    Time frame: 30 days

  2. Length of hospital stay

    Time frame: 1 - 90 days

  3. Length of stay in the intensive care unit

    Time frame: 0 - 90 days

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2013
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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