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OpenTrials
Completed

NCT Number: NCT03943355

Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period in our institution.

Completed

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Key information

Age range

17 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

The nonoperative management (NOM) protocol with angioembolization (AE) presents a trend in dealing with trauma patients with blunt splenic injury (BSI). This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016.

Exclusion criteria

  • Patients younger than 16 years
  • Patients who died in the emergency department

Treatment and study plan

Patient before cohort (2005-2010)

Other

The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.

Patient after cohort (2011-2016)

Other

The protocol of NOM became more aggressively and strictly adhered to since 2011.

Primary outcomes

  1. The numbers of associated complications and mortality

    Time frame: up to 6 months

    The primary outcome of interest in this study would be the associated complications and mortality.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 9, 2019
Registry last updated
May 9, 2019

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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