Impact of Blood Transfusion on Antibiotic Levels in Trauma Patients
Antibiotic Concentrations After MassivE Transfusion (ACME) Study
This study looks at how blood transfusions affect the levels of antibiotics in trauma patients to see if we can improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 417 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brooke Army Medical Center Federal |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06699901 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how the volume of blood transfusions affects the plasma concentration of antibiotics in trauma patients. Participants who meet specific trauma criteria and receive certain antibiotics during their hospital stay will be enrolled, with a focus on those undergoing massive transfusions. Blood samples will be collected at multiple time points post-antibiotic infusion to analyze concentration variations. The study aims to enhance understanding of antibiotic dosing in severely wounded patients receiving blood products, utilizing statistical methods for data analysis.
Who should consider this trial
Good fit: Ideal candidates include hospitalized trauma patients receiving specific antibiotics and undergoing blood transfusions.
Not a fit: Patients under 18 years of age, pregnant individuals, or those who have received the same antibiotic recently will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved antibiotic dosing strategies for trauma patients, potentially reducing infection rates.
How similar studies have performed: While the specific relationship between blood transfusion volume and antibiotic concentration is not extensively studied, similar approaches in trauma care have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receives ampicillin/sulbactam, cefazolin, cefepime, ceftriaxone, clindamycin, ertapenem, levofloxacin, metronidazole or pipercillin/tazobactam at any dose * Hospitalized or anticipated hospital admission Exclusion Criteria: * Received the same antibiotic within the past 5 half-lives of the drug (e.g. received the same antibiotic during a recent interval) * \<18 years of age * Known pregnancy * Known Prisoner
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Julie A Rizzo, MD — Brooke Army Medical Center
- Study coordinator: Steven G Schauer, DO
- Email: steven.g.schauer.mil@army.mil
- Phone: 2109160808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.