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

NCT04866953 | Completed DMC

• 1 other identifier: APP-21-02050
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Blood Transfusion Complication; Death

Keywords

trauma; massive transfusion protocol; ultra massive transfusion protocol; mortality; outcomes

Outcome Measures

Primary Outcomes (1)

• 24-hour mortality

  24-hour mortality (yes/no)

  24 hours

Secondary Outcomes (8)

• ICU length of stay

  through study completion, an average of 1 year

• hospital length of stay

  through study completion, an average of 1 year

• mechanical ventilator days

  through study completion, an average of 1 year

• complications

  through study completion, an average of 1 year

• Multiple organ system failure

  through study completion, an average of 1 year

Study Arms (2)

<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

>/=30 units PRBC

Patients who underwent surgery within 24 hours of admission and received \>/=30 units of pRBC within 24 hours.

Other: Blood transfusion

Interventions

Blood transfusion OTHER

Number of units of blood received within 24 hours of admission

<30 units PRBC; >/=30 units PRBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Irvine: collaborator
• University of California, Davis: collaborator
• University of Texas: collaborator
• University of Miami: collaborator
• University of Chicago: collaborator
• Medical College of Wisconsin: collaborator
• Tulane University School of Medicine: collaborator
• University of Arkansas: collaborator

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (23)

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  PMID: 25647203 RESULT

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  PMID: 10707230 RESULT

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  PMID: 27083965 RESULT

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• Johnson JL, Moore EE, Kashuk JL, Banerjee A, Cothren CC, Biffl WL, Sauaia A. Effect of blood products transfusion on the development of postinjury multiple organ failure. Arch Surg. 2010 Oct;145(10):973-7. doi: 10.1001/archsurg.2010.216.

  PMID: 20956766 RESULT

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  PMID: 12777902 RESULT

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  PMID: 17249446 RESULT

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  PMID: 24147731 RESULT

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  PMID: 28591469 RESULT

• Vaslef SN, Knudsen NW, Neligan PJ, Sebastian MW. Massive transfusion exceeding 50 units of blood products in trauma patients. J Trauma. 2002 Aug;53(2):291-5; discussion 295-6. doi: 10.1097/00005373-200208000-00017.

  PMID: 12169936 RESULT

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  PMID: 21174480 RESULT

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  PMID: 15983575 RESULT

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  PMID: 15761334 RESULT

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  PMID: 2048855 RESULT

• Major FR, Pickering TA, Stefanescu K, Singh M, Clark DH, Inaba K, Nahmias JT, Tay-Lasso EL, Alvarez C, Chen JL, Ahmed F, Kaslow OY, Tong JL, Xiao J, Hall E, Elkhateb R, Bahgat Y, Tatum D, Simpson JT, Singh S, Klein NJ, Applegate RL 2nd, Kuza CM. A Retrospective Study of Ultramassive Transfusion in Trauma Patients: Is There a Value After Which Additional Transfusions Are Futile? Anesth Analg. 2025 Nov 1;141(5):1126-1136. doi: 10.1213/ANE.0000000000007569. Epub 2025 Oct 20.

  PMID: 40445862 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Transfusion Reaction; Death

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Catherine M Kuza, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 30, 2021
• Study Start: August 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)