Red Blood Cell Collection System Evaluation

Recruiting at 1 trial location

Overseen By Jack Rhodes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terumo BCT

Must not be taking: AABB deferral list

Disqualifiers: Pregnancy, Blood disorders, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 42 days

37 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that treatment with any medication on the site deferral list could affect eligibility. It's best to check with the trial site to see if your medications are on that list.

What data supports the effectiveness of the Trima Accel Automated Blood Collection System treatment?

The Trima Accel system has been shown to effectively collect blood components like red blood cells and platelets, ensuring high quality and safety for transfusions. Studies have demonstrated its efficiency in collecting double dose platelets and maintaining donor safety, which suggests its reliability in automated blood collection. ^{1 2 3 4 5}

Is the Trima Accel Automated Blood Collection System safe for human use?

The Trima Accel Automated Blood Collection System is generally considered safe for human use. Studies show that the safety record of automated red blood cell collection, including the Trima Accel system, is excellent, with manageable long-term effects similar to those of traditional blood donation methods. ^{1 3 4 6 7}

How is the Trima Accel Auto RBC Collection treatment different from other treatments?

The Trima Accel Auto RBC Collection system is unique because it automates the collection of multiple blood components, such as red blood cells, platelets, and plasma, in a single session, which can reduce costs and improve efficiency compared to traditional methods that require separate procedures for each component. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for individuals who can participate in a study to test the performance of a blood collection system. Specific eligibility criteria are not provided, but typically participants would be healthy volunteers or patients meeting certain health standards.

Inclusion Criteria

Participants must agree to report AEs throughout their participation in the study

Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study

Given written informed consent

Exclusion Criteria

Serum ferritin <12 ng/mL

Has previously completed this study with data included in the EAS

Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical trial)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C

42 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Trima Accel Auto RBC Collection

Trial Overview The trial is testing how well leukoreduced red blood cells (RBCs), collected using the Trima Accel System with Non-DEHP sets and stored for 42 days, survive in the body after transfusion.

Participant Groups

Group I: Healthy adult participants Experimental Treatment 1 Intervention

Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C.

Trima Accel Auto RBC Collection is already approved in United States, European Union for the following indications:

Approved in United States as Trima Accel for:

• Collection of leukoreduced red blood cells
• Collection of platelets
• Collection of plasma

Approved in European Union as Trima Accel for:

• Collection of leukoreduced red blood cells
• Collection of platelets
• Collection of plasma

Who Is Running the Clinical Trial?

Terumo BCT

Lead Sponsor

Trials

22

Recruited

4,600+

Findings from Research

The new Trima system for collecting blood components produced quality results comparable to standard methods, with in vivo RBC recovery rates of 76.8% for test units and 77.1% for control units, indicating its efficacy in maintaining component quality.

Donor safety was confirmed with no major adverse reactions reported during 68 procedures, and all collected components met international standards for transfusion, suggesting the system is safe and reliable for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an automated system for the collection of packed RBCs, platelets, and plasma. Elfath, MD., Whitley, P., Jacobson, MS., et al.[2019]

The study involved 34 subjects who underwent both test and control procedures, demonstrating that the new Trima Accel V6.0 system allows for the collection of red blood cells (RBCs) with improved volume and hemoglobin yield due to in-line leukofiltration and automated addition of saline-adenine-glucose-mannitol (SAGM).

Both the test and control procedures showed low post-storage hemolysis (less than 0.8%) and residual white blood cell counts (less than 1 × 10^6/unit), indicating that the new system is safe and effective for producing high-quality RBC units that comply with EU standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red cell apheresis with automated in-line filtration. Matthes, G., Ingilizov, M., Dobao, ML., et al.[2021]

The introduction of Trima Accel software version 6.4 significantly reduced low-flow and no-flow alerts during plateletpheresis procedures, with alerts dropping from 55.3% to 16.6% and from 45.0% to 7.8%, respectively, indicating improved operational efficiency.

Version 6.4 also demonstrated higher collection efficiency (69.7%) and collection rate (7.7 × 10^9/min) compared to version 5.1.9, suggesting that the new autoflow management system enhances the overall effectiveness of platelet collection procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of autoflow management on flow-rate alerts, collection efficiency, and collection rate during plateletpheresis. Feng, Q., Xu, J., Li, C., et al.[2021]

The Trima Accel apheresis instrument demonstrated high efficiency in collecting double dose platelets, achieving a median platelet yield of 3.7 × 10^11 from 110 donors.

The study reported a mean collection efficiency of 74.99% and a collection rate of 0.096 × 10^11 platelets per minute, indicating the instrument's effectiveness in plateletpheresis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Trima Accel cell separator in the double dose plateletpheresis. Keklik, M., Korkmaz, S., Kalan, U., et al.[2017]

The Trima Accel (TA) device successfully collected hyperconcentrated platelets at a target concentration of 5000 x 10(3) PLTs/microl, achieving a collection efficiency of 47.5% and a collection rate of 5.9 x 10(9) PLTs/min, indicating its potential for high-quality platelet concentrates.

Despite its effectiveness, the study suggests that further improvements are needed to enhance the productivity of the TA device beyond its current validated limit of 4000 x 10(3) PLTs/microl.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collection of hyperconcentrated platelets with Trima Accel. Ringwald, J., Duerler, T., Frankow, O., et al.[2019]

Automated red cell collection is considered to have an excellent safety record, with physiological and cognitive responses similar to those seen in manual collection, suggesting it is a safe alternative.

While manual collection has been used for nearly a century and is assumed to be safe, automated collection has proven to be effective and manageable in terms of long-term effects like erythropoietic response and iron loss, comparable to those from repeated whole blood donation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of RBC apheresis and whole blood donation in allogeneic and autologous blood donors. Popovsky, MA.[2006]

The Gambro TRIMA automated device effectively produces red cell concentrates, platelets, and plasma, allowing for efficient collection of blood components in a single session, which can reduce costs and administrative burdens.

In a study involving 10 thrombocytopenic patients, the platelets collected showed good in vivo recovery after transfusion, with an average corrected count increment (CCI) of 28 x 10(3) microL(-1) after 1 hour, indicating their efficacy for patient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated collection of blood components: their storage and transfusion. Rock, G., Moltzan, C., Alharbi, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an automated system for the collection of packed RBCs, platelets, and plasma. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Red cell apheresis with automated in-line filtration. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The effects of autoflow management on flow-rate alerts, collection efficiency, and collection rate during plateletpheresis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the Trima Accel cell separator in the double dose plateletpheresis. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Collection of hyperconcentrated platelets with Trima Accel. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety of RBC apheresis and whole blood donation in allogeneic and autologous blood donors. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Automated collection of blood components: their storage and transfusion. [2022]