UltraMTP in Adult Trauma Patients Undergoing Surgery Within 24 Hours: Effects on Mortality and Clinical Outcomes

March 3, 2024 updated by: Catherine Kuza, MD, University of Southern California

At What Point is Blood Transfusion Futile in Trauma?: A Retrospective Study of Ultra Massive Transfusion Protocol in Adult Trauma Patients Undergoing Surgery Within 24 Hours and Effects on Mortality and Clinical Outcomes

The purpose of this study is to determine the effects of ultraMTP (>/=30 units pRBC within 24 hours) in trauma patients on mortality and secondary outcomes. The aim is to determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: To determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.

Intervention: Blood transfusions administered to adult trauma patients undergoing surgery within 24 hours of admission.

Objectives/Purpose: The main objective of this study is to examine the outcomes associated with large volume transfusions at U.S. level I trauma centers in adult trauma patients undergoing surgery within 24 hours of admission. The investigators aim to determine the mortality rate associated with ultraMTP (defined as >/= 30 units pRBC within 24 hours), and the effects of ultraMTP on secondary outcomes. The investigators would also like to compare outcomes among patients who receive various amounts of pRBC units within 24 hours. The information learned through this study will aid in determining whether there is a threshold transfusion amount, after which outcomes significantly worsen, and resuscitation efforts are futile and should cease, in order to save hospital resources, time, and costs.

Study Population/Sample Characteristics: Adult trauma patients requiring surgery within 24 hours of admission who receive blood products.

Study Methodology: This is a multicenter, retrospective observational study.

Study Endpoints/Outcomes:

  • Primary outcome: 24-hour mortality (from the time of admission until 24 hours)
  • Secondary outcomes: 1. ICU length of stay (LOS); 2. hospital LOS; 3. MV days; 4. Complications; 5. Multiple organ system failure; 6. in hospital mortality; 7. 30-day mortality; 8. discharge disposition.

Statistics/Analysis Plans:

The investigators will construct a logistic regression prediction model to 1) find the cut point classifications for pRBC units that optimize model prediction and 2) find additional variables that improve the predictive ability of our model. Previous studies on pRBC units and mortality have used different category cut points for pRBC units. The investigators will examine the functional form of pRBC units in its relationship with mortality to determine if there is a "plateau" effect of increasing pRBC units on mortality. The investigators will use this information to guide the classification of pRBC unit categories, comparing AIC values from several models with differing pRBC category classification cut off points to determine which of these are most highly associated with mortality. Using these categories, the investigators will then construct the prediction model, using the variables defined in Section 12. Interactions between these candidate predictors variables and pRBC units will additionally be considered. Model validation will be performed using k-folds cross-validation. Model performance will be evaluated by examining discriminative ability (area under ROC curve), calibration metrics, and optimism.

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of the University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult trauma patients who underwent surgery within the first 24 hours of admission, who received blood products in the first 24 hours.

Description

Inclusion Criteria:

  • >/= 18 years old
  • trauma patient
  • undergoing surgery within first 24 hours of admission
  • received blood products within 24 hours of admission

Exclusion Criteria:

  • <18-years-old
  • no surgery within the first 24 hours
  • did not receive blood products within the first 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
<30 units PRBC
Patients who underwent surgery within 24 hours of admission and received less than 30 units of pRBC within 24 hours.
Other: Blood transfusion
Number of units of blood received within 24 hours of admission
>/=30 units PRBC
Patients who underwent surgery within 24 hours of admission and received >/=30 units of pRBC within 24 hours.
Other: Blood transfusion
Number of units of blood received within 24 hours of admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour mortality
Time Frame: 24 hours
24-hour mortality (yes/no)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: through study completion, an average of 1 year
ICU length of stay (days)
through study completion, an average of 1 year
hospital length of stay
Time Frame: through study completion, an average of 1 year
hospital length of stay (days)
through study completion, an average of 1 year
mechanical ventilator days
Time Frame: through study completion, an average of 1 year
mechanical ventilator days
through study completion, an average of 1 year
complications
Time Frame: through study completion, an average of 1 year
complications (yes/no)
through study completion, an average of 1 year
Multiple organ system failure
Time Frame: through study completion, an average of 1 year
Multiple organ system failure (yes/no)
through study completion, an average of 1 year
In-hospital mortality
Time Frame: through study completion, an average of 1 year
In-hospital mortality (yes/no)
through study completion, an average of 1 year
30-day mortality
Time Frame: 30 days
30-day mortality (yes/no)
30 days
discharge disposition
Time Frame: through study completion, an average of 1 year
discharge disposition
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

University of Miami
University of Chicago
Medical College of Wisconsin
University of California, Davis
University of California, Irvine
University of Texas
University of Arkansas
Tulane University School of Medicine

Investigators

  • Principal Investigator: Catherine M Kuza, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP-21-02050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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