Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

Completed

• Conditions: Blunt Injuries
• Interventions: Other: Patient before cohort (2005-2010); Other: Patient after cohort (2011-2016)

• Registration Number: NCT03943355
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-01-01
• Primary Completion: 2015-10-30
• Study Completion: 2015-12-31
• Status Verified: 2019-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-08
• Last Update Submitted: 2019-05-08
• Study First Posted: 2019-05-09
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nonoperative management protocol with angioembolization	Patient after cohort (2011-2016)	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.
Nonoperative management protocol with angioembolization	Patient before cohort (2005-2010)	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.

Primary Outcome Measures

Name	Time	Method
The numbers of associated complications and mortality	up to 6 months	The primary outcome of interest in this study would be the associated complications and mortality.