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

NCT ID: NCT04866953

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Trauma; Blood Transfusion Complication; Death

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

<30 units PRBC

Patients who underwent surgery within 24 hours of admission and received less than 30 units of pRBC within 24 hours.

Blood transfusion

Intervention Type: OTHER

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.

Blood transfusion

Intervention Type: OTHER

Number of units of blood received within 24 hours of admission

Interventions

Blood transfusion

Number of units of blood received within 24 hours of admission

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

Tulane University School of Medicine

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Catherine Kuza, MD

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine M Kuza, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Keck School of Medicine of the University of Southern California

Los Angeles, California, United States

Countries

United States

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Other Identifiers

APP-21-02050

Identifier Type: -

Identifier Source: org_study_id