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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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