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NCT06699901 · ClinicalTrials.gov registry record
Antibiotic Concentrations After MassivE Transfusion Study
A clinical trial of Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents, sponsored by Brooke Army Medical Center.
- Recruiting
- Registry status
- 417
- Enrollment target
- 2
- Study locations
NCT06699901 is a study of Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents that is actively recruiting participants, run by Brooke Army Medical Center. The registered enrollment target is 417 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT06699901, a study of Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents, is actively recruiting participants, sponsored by Brooke Army Medical Center.
- RECRUITING
- Registry status
- 417 participants
- Enrollment target
- 2
- Study locations
Study Summary
Combat and civilian trauma frequently result in open wounds that are at risk for infection. Data from the Department of Defense Trauma Registry demonstrate that 74% of combat trauma casualties have an open wound. The Committee on Tactical Combat Casualty Care, the Prolonged Field Care Working Group, and the Joint Trauma System clinical practice guidelines recommend antibiotic prophylaxis for open wounds after trauma. The civilian setting has similar risks of open wound infection after trauma. In parallel, current practice guidelines recommend the aggressive use of balanced blood products during resuscitation. It remains unclear how the replacement of blood after hemorrhage through transfusion may affect antibiotic concentrations. Data is necessary to better understand this relationship to enhance wound prophylaxis antibiotic dosing, particularly in severely wounded casualties who receive blood products during massive transfusions. It remains unclear how these resuscitation methods may alter pharmacokinetics. The investigators hypothesize that drug concentrations decrease in direct relation to the amount of blood transfused during low-volume, massive, and supermassive transfusion after trauma compared to patients who receive no blood products. The investigators seek to understand the relationship between drug concentrations and blood product administration using a non-compartmentalized model in the setting of hemorrhage. Specifically, they will (1) obtain drug concentrations at regular intervals during the first 12-18 hours after administration of antibiotics, (2) determine how much blood products and fluids are transfused during the 12 hours prior to antibiotic and 24 hours post-administration, and (3) perform data modeling to understand the relationship between blood transfusions and drug concentrations to inform data-driven dosing models. Liquid chromatography methods will be developed to measure drug concentrations. The investigators will conduct a prospective, m
Conditions Studied
Interventions
- OTHER Control Group
- OTHER Massive Transfusion Group
Study Locations (2)
Colorado
- University of Colorado Hospital - Aurora
Texas
- Brooke Army Medical Center - Fort Sam Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2024-09-30 |
| Est. Completion | 2027-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06699901
The ClinicalTrials.gov registry entry for NCT06699901 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 417 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brooke Army Medical Center, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents appearing as the primary indexed condition, and to 2 interventions - of which Control Group is the first listed.
NCT06699901 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Texas.
Frequently Asked Questions
What is clinical trial NCT06699901 about?
NCT06699901 is a clinical study titled "Antibiotic Concentrations After MassivE Transfusion Study". Combat and civilian trauma frequently result in open wounds that are at risk for infection. Data from the Department of Defense Trauma Registry demonstrate that 74% of combat trauma casualties have an open wound. The Committee on Tactical Combat Casualty Care, the Prolonged Field Care Working Group,...
What is the current status of trial NCT06699901?
This trial is currently recruiting. The enrollment target is 417 participants. The study started on 2024-09-30. Estimated completion is 2027-09-30.
What conditions does trial NCT06699901 study?
This clinical trial studies the following conditions: Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents.
What interventions are being tested in trial NCT06699901?
The interventions under investigation include: Control Group (OTHER), Massive Transfusion Group (OTHER).
Who is sponsoring clinical trial NCT06699901?
This trial is sponsored by Brooke Army Medical Center, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06699901 being conducted?
This trial has 2 study locations across Colorado, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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