NCT05785143

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
81mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress36%
Jul 2022Dec 2032

Study Start

First participant enrolled

July 20, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

10.5 years

First QC Date

March 14, 2023

Last Update Submit

March 14, 2023

Conditions

The Precision Personal Timeline in Definitive Surgery Associated With Outcome

Keywords

multi-traumalactatedefinitive orthopedic operation

Outcome Measures

Primary Outcomes (1)

  • EQ5D5L

    The functional outcome of daily activity

    1 year

Interventions

Utilizing dry lab database to analyze the prognostic factors of multi-trauma patients and determine the optimal timing of definitive orthopedic operationPROCEDURE

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pelvic fracture patients

You may qualify if:

  • (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)

You may not qualify if:

  • death before into undergoing surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, North District, 404327, Taiwan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 27, 2023

Study Start

July 20, 2022

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

TW(1)