NCT03943355

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

May 7, 2019

Last Update Submit

May 8, 2019

Conditions

Blunt Injuries

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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)Other: Patient after cohort (2011-2016)

Interventions

Patient before cohort (2005-2010)OTHER

The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.

Nonoperative management protocol with angioembolization
Patient after cohort (2011-2016)OTHER

The protocol of NOM became more aggressively and strictly adhered to since 2011.

Nonoperative management protocol with angioembolization

Eligibility Criteria

Age17 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016.

You may not qualify if:

  • Patients younger than 16 years
  • Patients who died in the emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds, Nonpenetrating

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • TSANG-TANG Hsieh, MD

    Chang Gung Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

January 1, 2014

Primary Completion

October 30, 2015

Study Completion

December 31, 2015

Last Updated

May 9, 2019

Record last verified: 2019-05