417 Participants Needed

Massive Transfusion for Blood Dyscrasia

(ACME Trial)

Recruiting at 1 trial location
JM
SG
SG
Overseen BySteven G Schauer, DO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brooke Army Medical Center
Must be taking: Antibiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how blood transfusions affect antibiotic levels in the body after trauma. This is crucial because open wounds from injuries can become infected, and antibiotics help prevent this. Researchers will compare drug levels in patients receiving varying amounts of blood transfusions. Individuals who have been injured, are in the hospital or expected to be admitted, and are given specific antibiotics like ampicillin or cefazolin may be suitable for this trial. Participants will contribute to improving antibiotic use in preventing infections in trauma cases.

As an unphased trial, this study offers participants the chance to contribute to significant research that could enhance antibiotic use in trauma care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you've received the same antibiotic within the past 5 half-lives of the drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that massive transfusions, which involve giving a large amount of blood, can cause certain side effects. Studies have found that up to 97% of patients receiving these transfusions may experience low calcium levels, which can become serious if the levels drop too much. However, these transfusions often save lives after severe injuries. While this study examines the effectiveness of antibiotics given with these transfusions, understanding the risks of large blood transfusions remains important. Awareness of these effects can help doctors manage and improve treatment during critical situations.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how antibiotic levels are affected during massive blood transfusions. While current treatments focus on stabilizing patients with blood and antibiotics separately, this study looks at how well antibiotics maintain their effectiveness when a patient receives a lot of blood. The findings could help tailor antibiotic dosages more precisely during such critical procedures, potentially improving outcomes for patients undergoing massive transfusions.

What evidence suggests that this trial's treatments could be effective for blood dyscrasia?

Research has shown that specific blood transfusion methods can help trauma patients survive. Studies have found that patients receiving these transfusions sometimes have better survival chances shortly after their injury, such as in the emergency room and during the first 24 hours. One study discovered that having more platelets compared to red blood cells during a transfusion was linked to better outcomes. In this trial, participants in the Massive Transfusion Group will receive at least 3 units of blood, while those in the Control Group will ideally receive no blood or up to 2 units. However, the effects of these transfusions on antibiotic levels in the body remain unclear. This study is important because it will reveal how blood transfusions change antibiotic levels, potentially improving infection prevention in trauma patients.12678

Who Is on the Research Team?

JA

Julie A Rizzo, MD

Principal Investigator

Brooke Army Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently taking antibiotics like ampicillin or cefazolin.
I am currently in the hospital or expect to be admitted soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Observation

Participants are observed for antibiotic plasma concentration after trauma and blood transfusion

18 hours
Continuous monitoring during hospitalization

Data Collection

Blood samples are collected at six intervals post-antibiotic infusion for analysis

24 hours
6 sample collections

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Antibiotic Concentrations

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Massive Transfusion GroupExperimental Treatment1 Intervention
Group II: Control GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials
134
Recruited
28,100+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

The Metis Foundation

Collaborator

Trials
13
Recruited
750+

University of Colorado Health

Collaborator

Trials
4
Recruited
1,000+

Citations

Massive transfusion and massive transfusion protocol - PMC

Recently, protocol based management of these patients using massive transfusion protocol have shown improved outcomes. This section discusses in detail both ...

Massive transfusion: a review - Moore - Annals of Blood

Civilian data has been mixed regarding improved outcomes with the use of LTOWB, with some studies finding improvements in trauma bay survival, 24-hour and ...

Is There a Limit to Massive Blood Transfusion After Severe ...

The survival rates in the 4 subgroups of transfusion were 33%, 29%, 27%, and 27%. The highest levels of MBT among survivors were 68 U in 1 patient and 64 U in 2 ...

High platelet-to-red blood cell ratio and outcomes in trauma ...

In this multicenter study, a high PLT/RBC ratio (> 0.7) was associated with improved survival in trauma patients requiring massive transfusions, ...

Massive Transfusion Protocol and Outcome of Patients with ...

Results: The amount of blood product transfused was higher in the MTP group. The 42-day mortality rate (42.1% vs. 1.5%, p < 0.001) and the rate ...

ACS TQIP MASSIVE TRANSFUSION IN TRAUMA ...

Hemorrhage is the most common cause of death within the first hour of arrival to a trauma center. More than 80 percent of deaths in the operating room (OR).

Massive blood transfusion in adolescents and adults - UpToDate

Massive transfusion has been arbitrarily defined as the replacement by transfusion of ≥10 units of whole blood (WB) or red blood cells (RBCs) ...

Current controversies and advances in massive transfusion

This review addresses ongoing controversies and advancements in MTPs, including optimal blood product ratios, the role of viscoelastic hemostatic assays (VHAs),