Antibiotic Concentrations After MassivE Transfusion Study

RecruitingOBSERVATIONAL
Enrollment

417

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

July 30, 2027

Study Completion Date

September 30, 2027

Conditions
Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents
Interventions
OTHER

Massive Transfusion Group

This group includes trauma patients who receive a massive transfusion, defined as the transfusion of at least 3 units of blood. Blood samples are collected at six specific timepoints following the administration of antibiotics to analyze plasma antibiotic concentrations. Existing clinical draws will be used whenever possible to minimize additional venipunctures, with a maximum of two dedicated research-only draws allowed if necessary. Data analysis will assess the impact of large blood transfusions on antibiotic pharmacokinetics over time, adjusting for factors such as kidney function.

OTHER

Control Group

This group consists of trauma patients who receive minimal or no blood transfusions (up to 2 units of blood). Blood samples are also collected at six designated timepoints after antibiotic administration to measure plasma antibiotic concentrations. As with the massive transfusion group, clinical draws will be coordinated whenever possible to obtain research samples, with a maximum of two dedicated research-only draws if needed. Data analysis will compare antibiotic concentration trends in this group with those in the massive transfusion group to understand the effects of blood transfusion volume on antibiotic pharmacokinetics.

Trial Locations (2)

78234

NOT_YET_RECRUITING

Brooke Army Medical Center, Fort Sam Houston

80045

RECRUITING

University of Colorado Hospital, Aurora

All Listed Sponsors
collaborator

Congressionally Directed Medical Research Programs

FED

collaborator

The Metis Foundation

OTHER

collaborator

University of Colorado Health

OTHER

lead

Brooke Army Medical Center

FED