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CompletedNCT03943355Updated May 9, 2019

Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

An observational study in Blunt Injuries, sponsored by Chang Gung Memorial Hospital. Completed. Open to participants aged 17 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-05-09.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
399
Ages
17 Years to 100 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

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In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 859 are open to participants now.

This study's enrollment of 399 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A retrospective study was performed on adult trauma patients with BSI who were admitted from 2005 to 2016. The patients were divided into before cohort (2005-2010) and after cohort (2011-2016).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
399 participants (actual)
Patient registry
No

Groups and cohorts

  • Nonoperative management protocol with angioembolization

    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.

    Other: Patient before cohort (2005-2010) · Other: Patient after cohort (2011-2016)

Interventions

  • OtherPatient before cohort (2005-2010)

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

  • OtherPatient after cohort (2011-2016)

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

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What researchers measure

Primary outcomes

  1. The numbers of associated complications and mortality

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

    Time frame: up to 6 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03943355
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
May 9, 2019
Start date
Jan 1, 2014
Primary completion
Oct 30, 2015
Completion
Dec 31, 2015
Last update
May 9, 2019

Study contacts

TSANG-TANG Hsieh, MD
study chair · Chang Gung Memorial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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