Actively Recruiting

Age: 18Years +
All Genders
ID06699901

Antibiotic Concentrations After MassivE Transfusion (ACME) Study

Led by Brooke Army Medical Center ยท Updated on 2025-02-11

417

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

Sponsors

B

Brooke Army Medical Center

Lead Sponsor

C

Congressionally Directed Medical Research Programs

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand how the volume of blood transfusions affects antibiotic levels in patients with open wounds due to trauma. It addresses a common problem where many combat and civilian trauma patients receive blood transfusions, but it is unclear how these transfusions change antibiotic concentrations used to prevent infections in wounds. The study will develop data-driven dosing models based on the relationship between blood transfusions and antibiotic levels. Participants include trauma patients who receive antibiotics such as ampicillin/sulbactam, cefazolin, and others during hospitalization. They are grouped into those receiving minimal or no blood transfusions (up to 2 units) and those receiving massive transfusions (at least 3 units). Blood samples are collected at six set timepoints after antibiotic administration, often using routine clinical blood draws with limited extra sampling. During the study, blood samples are processed and analyzed to measure antibiotic concentrations. Researchers will examine how transfused blood volume influences these levels using statistical models and data collected over time up to 30 days post-enrollment. The study ensures participant data privacy under HIPAA and involves minimal additional risks, qualifying for a waiver of informed consent. The total monitoring period extends up to 30 days after enrollment with ongoing data analysis.

CONDITIONS

Brief Title

Antibiotic Concentrations After MassivE Transfusion Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Receives ampicillin/sulbactam, cefazolin, cefepime, ceftriaxone, clindamycin, ertapenem, levofloxacin, metronidazole or pipercillin/tazobactam at any dose
  • Hospitalized or anticipated hospital admission
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Received the same antibiotic within the past 5 half-lives of the drug
  • Under 18 years of age
  • Known pregnancy
  • Known prisoner status

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 18 hours after antibiotic administration

Participants who meet trauma criteria and receive specified antibiotics during hospitalization have blood samples collected at six intervals after antibiotic infusion to measure plasma antibiotic concentrations. Samples are often collected during routine clinical blood draws to minimize additional venipunctures, with up to two extra research-only draws if needed.

6 blood sample collections (aligned with clinical draws when possible)

Long-term Monitoring

Duration - Up to 30 days

Participants are observed for up to 30 days post-enrollment to assess blood transfusion volume and antibiotic concentration levels, with data collected for analysis of pharmacokinetics and transfusion effects.

Data collected through hospital records and clinical follow-up

Trial Site Locations

Total: 2 locations

1

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Brooke Army Medical Center

Fort Sam Houston, Texas, United States, 78234

Not Yet Recruiting

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Research Team

S

Steven G Schauer, DO

J

Jessica Mendez, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Early application of topical antibiotic powder in open-fracture wounds: A strategy to prevent biofilm formation and infections.

Kimberly M Burbank, Steven G Schauer, Robert A De Lorenzo...

https://pubmed.ncbi.nlm.nih.gov/33937714

Prehospital Combat Wound Medication Pack Administration in Iraq and Afghanistan: A Department of Defense Trauma Registry Analysis.

Steven G Schauer, Jason F Naylor, Yousef M Ahmed...

https://pubmed.ncbi.nlm.nih.gov/32969008

An Analysis of 13 Years of Prehospital Combat Casualty Care: Implications for Maintaining a Ready Medical Force.

Steven G Schauer, Jason F Naylor, Andrew D Fisher...

https://pubmed.ncbi.nlm.nih.gov/33760684

A Descriptive Analysis of Supermassive Transfusion Recipients Among US and Coalition Forces During Combat Operations in Afghanistan and Iraq.

Andrew D Fisher, Jason S Lavender, Michael D April...

https://pubmed.ncbi.nlm.nih.gov/34741519

Association of Prehospital Blood Product Transfusion During Medical Evacuation of Combat Casualties in Afghanistan With Acute and 30-Day Survival.

Stacy A Shackelford, Deborah J Del Junco, Nicole Powell-Dunford...

https://pubmed.ncbi.nlm.nih.gov/29067429