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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

  • Clinicaltrials.gov identifier

    NCT03943355

  • Recruitment Status

    Completed

  • First Posted

    May 9, 2019

  • Last update posted

    May 9, 2019

Study Description

Brief 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.

  • Condition or Disease:Blunt Injuries
  • Intervention/Treatment: Other: Patient before cohort (2005-2010)
    Other: Patient after cohort (2011-2016)
  • Phase: N/A

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.

Study Design

  • Study Type: Observational
  • Actual Enrollment: 399 participants
  • Observational Model: Case-Control
  • Time Perspective: Retrospective
  • Official Title: Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries
  • Actual Study Start Date: January 2014
  • Actual Primary Completion Date: October 2015
  • Actual Study Completion Date: December 2015

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: 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)
The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.

Other: Patient after cohort (2011-2016)
The protocol of NOM became more aggressively and strictly adhered to since 2011.

Outcome Measures

  • Primary Outcome Measures: 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.

Eligibility Criteria

  • Ages Eligible for Study: 17 to 100 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: 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).

Criteria

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

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

Study Chair: TSANG-TANG Hsieh, MD Chang Gung Memorial Hospital

More Information

  • Responsible Party: Chang Gung Memorial Hospital
  • ClinicalTrials.gov Identifier: NCT03943355 History of Changes
  • Other Study ID Numbers: 102-4441B
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 9, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Wounds, Nonpenetrating Wounds and Injuries