Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

Blunt Injuries Clinical Trial

Official title:

Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943355
• Other study ID #: 102-4441B
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: December 31, 2015
• Est. primary completion date: October 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blunt Injuries
• Wounds and Injuries
• Wounds, Nonpenetrating

Intervention

Other:
• Patient before cohort (2005-2010)
The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.
• Patient after cohort (2011-2016)
The protocol of NOM became more aggressively and strictly adhered to since 2011.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The numbers of associated complications and mortality	The primary outcome of interest in this study would be the associated complications and mortality.	up to 6 months