Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

NCT ID: NCT03943355

Last Updated: 2019-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Blunt Injuries

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Patient before cohort (2005-2010)

Intervention Type OTHER

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

Patient after cohort (2011-2016)

Intervention Type OTHER

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

Interventions

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Patient before cohort (2005-2010)

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

Intervention Type OTHER

Patient after cohort (2011-2016)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TSANG-TANG Hsieh, MD

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Other Identifiers

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102-4441B

Identifier Type: -

Identifier Source: org_study_id

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