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

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ClinicalTrials.gov Identifier: NCT04866953
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : September 29, 2021
Sponsor:
Collaborators:
University of California, Irvine
University of California, Davis
University of Texas
University of Miami
University of Chicago
Medical College of Wisconsin
Tulane University School of Medicine
University of Arkansas
Information provided by (Responsible Party):
Catherine Kuza, MD, University of Southern California

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.

Condition or disease Intervention/treatment
Trauma Blood Transfusion Complication Death Other: Blood transfusion

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : August 15, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 24-hour mortality [ Time Frame: 24 hours ]
    24-hour mortality (yes/no)


Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: through study completion, an average of 1 year ]
    ICU length of stay (days)

  2. hospital length of stay [ Time Frame: through study completion, an average of 1 year ]
    hospital length of stay (days)

  3. mechanical ventilator days [ Time Frame: through study completion, an average of 1 year ]
    mechanical ventilator days

  4. complications [ Time Frame: through study completion, an average of 1 year ]
    complications (yes/no)

  5. Multiple organ system failure [ Time Frame: through study completion, an average of 1 year ]
    Multiple organ system failure (yes/no)

  6. In-hospital mortality [ Time Frame: through study completion, an average of 1 year ]
    In-hospital mortality (yes/no)

  7. 30-day mortality [ Time Frame: 30 days ]
    30-day mortality (yes/no)

  8. discharge disposition [ Time Frame: through study completion, an average of 1 year ]
    discharge disposition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866953


Contacts
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Contact: Catherine M Kuza, MD 9089176330 catherine.kuza@gmail.com
Contact: Jeffry T Nahmias, MD 9493073035 jnahmias1@yahoo.com

Locations
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United States, California
Keck School of Medicine of the University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Catherine M Kuza, MD    323-442-7400    catherine.kuza@med.usc.edu   
Sponsors and Collaborators
University of Southern California
University of California, Irvine
University of California, Davis
University of Texas
University of Miami
University of Chicago
Medical College of Wisconsin
Tulane University School of Medicine
University of Arkansas
Investigators
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Principal Investigator: Catherine M Kuza, MD University of Southern California
Publications of Results:

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Responsible Party: Catherine Kuza, MD, Assistant Professor of Anesthesiology, University of Southern California
ClinicalTrials.gov Identifier: NCT04866953    
Other Study ID Numbers: APP-21-02050
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catherine Kuza, MD, University of Southern California:
trauma
massive transfusion protocol
ultra massive transfusion protocol
mortality
outcomes
Additional relevant MeSH terms:
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Transfusion Reaction
Wounds and Injuries
Hematologic Diseases
Immune System Diseases