Blunt InjuriesNCT03943355
Nonoperative Management Protocol in Patients With Blunt Splenic Injuries
An observational study of Blunt Injuries, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 17 to 100 years
- Conditions the study is for
- Blunt Injuries
- What is being tested?
- Patient before cohort (2005-2010) and Patient after cohort (2011-2016)
- How many people
- 399 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016.
Who cannot join
- Patients younger than 16 years
- Patients who died in the emergency department
About this study
Official title: Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries
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.
Read the 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.
- Conditions
- Blunt Injuries
- Being tested
- Patient before cohort (2005-2010), Patient after cohort (2011-2016)
- Medical subject headings
- Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient before cohort (2005-2010)Other
The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.
Patient after cohort (2011-2016)Other
The protocol of NOM became more aggressively and strictly adhered to since 2011.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient before cohort (2005-2010); Other: Patient after cohort (2011-2016) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The numbers of associated complications and mortality
The primary outcome of interest in this study would be the associated complications and mortality.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Jan 2014
- Primary completion30 Oct 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt InjuriesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TSANG-TANG Hsieh, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943355
- Sponsor's protocol ID
- 102-4441B
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries
- ClinicalTrials.gov ID
- NCT03943355
- Acronym / sponsor ID
- 102-4441B
- Conditions
- Blunt Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonoperative management protocol with angioembolization | – | Other: Patient before cohort (2005-2010), Other: 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. |
Who may qualify
- Ages
- 17 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016.
Key exclusion criteria (2 listed)
- Patients younger than 16 years
- Patients who died in the emergency department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient before cohort (2005-2010)The NOM protocol with AE was recognized and accepted after our previous study reported in 2004. | Other | Nonoperative management protocol with angioembolization |
| Patient after cohort (2011-2016)The protocol of NOM became more aggressively and strictly adhered to since 2011. | Other | Nonoperative management protocol with angioembolization |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TSANG-TANG Hsieh, MD study chair
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Blunt Injuries, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The numbers of associated complications and mortality (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.