The Precision Personal Timeline in Definitive Surgery Associated With OutcomeNCT05785143
Timing of Damage Control Orthopedic Surgery
An observational study of The Precision Personal Timeline in Definitive Surgery Associated With Outcome, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Precision Personal Timeline in Definitive Surgery Associated With Outcome
- What is being tested?
- Utilizing dry lab database to analyze the prognostic factors of multi-trauma patients and determine the optimal timing of definitive orthopedic operation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jul 2022to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pelvic fracture patients
Who may be able to join
- (1) Injury severity score(ISS) > 16 with pelvicfracture or long bone fracture requiring surgical fixation (2) Patient age ≥ 20. Pathologic fracture was excluded. Our primary endpoint si mortality rate, secondary endpoints include ICU stay, ICU complications (Sepsis, Pneumonia, Multiple organ failure)
Who cannot join
- death before into undergoing surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hospital
Taichung, North District, 404327
About this study
Official title: Utilizing Dry Lab Database to Analyze the Prognostic Factors of Multi-trauma Patients and Determine the Optimal Timing of Definitive Orthopedic Operation
The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.
Read the detailed description
The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis.
The aim of our study is to analyze if serum lactate a predictive factor of optimal surgical timing in multi-trauma patients. In order to obtain more accurate data, we choose to utilize ili database and trauma database instead of National Health Insurance Research Database.
Multi-trauma patients from 2002 through 2022 were included to our study. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.
- Being tested
- Utilizing dry lab database to analyze the prognostic factors of multi-trauma patients and determine the optimal timing of definitive orthopedic operation
- Keywords
- multi-trauma, lactate, definitive orthopedic operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilizing dry lab database to analyze the prognostic factors of multi-trauma patients and determine the optimal timing of definitive orthopedic operationProcedure or surgery
to analyze if serum lactate a predictive factor of optimal surgical timing in multi-trauma patients. In order to obtain more accurate data, we choose to utilize ili database and trauma database instead of National Health Insurance Research Database.
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D5L
The functional outcome of daily activity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start20 Jul 2022
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Precision Personal Timeline in Definitive Surgery Associated With OutcomeStudies of the same condition, open and under way.
- More trials run by China Medical University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785143
- Sponsor's protocol ID
- CMUH111-REC2-110
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Dry Lab Database to Analyze the Prognostic Factors of Multi-trauma Patients and Determine the Optimal Timing of Definitive Orthopedic Operation
- ClinicalTrials.gov ID
- NCT05785143
- Acronym / sponsor ID
- CMUH111-REC2-110
- Keywords
- multi-trauma, lactate, definitive orthopedic operation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 27 Mar 2023 (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.
The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.
Detailed description
The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis.
The aim of our study is to analyze if serum lactate a predictive factor of optimal surgical timing in multi-trauma patients. In order to obtain more accurate data, we choose to utilize ili database and trauma database instead of National Health Insurance Research Database.
Multi-trauma patients from 2002 through 2022 were included to our study. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pelvic fracture patients
Key inclusion criteria (1 listed)
- (1) Injury severity score(ISS) > 16 with pelvicfracture or long bone fracture requiring surgical fixation (2) Patient age ≥ 20. Pathologic fracture was excluded. Our primary endpoint si mortality rate, secondary endpoints include ICU stay, ICU complications (Sepsis, Pneumonia, Multiple organ failure)
Key exclusion criteria (1 listed)
- death before into undergoing surgery
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 |
|---|---|---|
| Utilizing dry lab database to analyze the prognostic factors of multi-trauma patients and determine the optimal timing of definitive orthopedic operationto analyze if serum lactate a predictive factor of optimal surgical timing in multi-trauma patients. In order to obtain more accurate data, we choose to utilize ili database and trauma database instead of National Health Insurance Research Database. | Procedure or surgery | – |
Primary outcome
EQ5D5L
Time frame: 1 year
The functional outcome of daily activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Precision Personal Timeline in Definitive Surgery Associated With Outcome, run by China Medical University Hospital at 1 site in Taiwan.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
EQ5D5L (time frame: 1 year). 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 27 Mar 2023.