Nonoperative Management Protocol in Patients With Blunt Splenic Injuries
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|ClinicalTrials.gov Identifier: NCT03943355|
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment|
|Blunt Injuries||Other: Patient before cohort (2005-2010) Other: Patient after cohort (2011-2016)|
|Study Type :||Observational|
|Actual Enrollment :||399 participants|
|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|
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.
- 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.
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
|Study Chair:||TSANG-TANG Hsieh, MD||Chang Gung Memorial Hospital|