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Trial record 2 of 1142 for:    Protocol AE

Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943355
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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 Intervention/treatment
Blunt Injuries Other: Patient before cohort (2005-2010) Other: Patient after cohort (2011-2016)

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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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 1, 2014
Actual Primary Completion Date : October 30, 2015
Actual Study Completion Date : December 31, 2015

Group/Cohort 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.




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.



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Ages Eligible for Study:   17 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943355


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: TSANG-TANG Hsieh, MD Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03943355    
Other Study ID Numbers: 102-4441B
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Wounds, Nonpenetrating