Red Blood Cell Collection System Evaluation

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well red blood cells, collected and stored in a specific way, recover in the body after 42 days. The Trima Accel Auto RBC Collection System collects these cells to evaluate their effectiveness after storage. The study seeks healthy adults who can donate blood and adhere to the study schedule. Participants have the chance to help improve blood donation storage for future needs. As an unphased trial, this study allows participants to contribute to advancements in blood storage techniques that could benefit future patients.

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 prior data suggests that the Trima Accel Auto RBC Collection is safe for red blood cell collection?

Research has shown that the Trima Accel Auto RBC Collection system, used for collecting red blood cells, is generally well-tolerated. In studies, some users reported issues like clots in the lines or sensors. However, equipment issues, not the blood collection process itself, usually cause these problems.

The system includes safety features to prevent problems like air bubbles entering the bloodstream. These issues are rare and can often be avoided with proper equipment use.

Overall, the Trima Accel system is widely used and considered safe for collecting blood. Prospective trial participants should ask the researchers about the specific safety measures in place. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trima Accel Auto RBC Collection system because it offers a novel way to collect and store red blood cells for transfusions. Unlike traditional methods, this system allows red blood cells to be stored for up to 42 days at 2-6°C, which could improve the availability and quality of blood for transfusions. The use of radiolabeled, autologous infusions aims to ensure that the blood cells are both safe and effective when reintroduced into the body. This innovation could lead to more efficient blood management and better outcomes for patients requiring transfusions.

What evidence suggests that the Trima Accel Auto RBC Collection is effective for red blood cell collection?

Studies have shown that the Trima Accel system effectively collects high-quality blood components, including red blood cells (RBCs) with fewer white blood cells. Research indicates that these RBCs remain safe and maintain their quality even after 42 days of storage. The system uses special tubing to keep the cells in good condition during this time. In this trial, healthy adult participants will receive radiolabeled, autologous infusions of LR-RBC components collected using the Trima Accel system to evaluate its performance. Initial findings suggest that the collected red blood cells function well after extended storage, demonstrating the system's effectiveness in preserving blood cells for future use. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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]

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 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]

Citations

1. terumobct.com terumobct.com/en/gl/products-services/global-blood-solutions/global-blood-solutions-products/trima.html

Trima Accel Automated Blood Collection System With your Trima Accel system, you can collect leukoreduced platelets, leukoreduced plasma, and leukoreduced or non-leukoreduced red blood cells in any ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4025052/

Red Cell Apheresis with Automated In-Line Filtration - PMC The objective of this study was to provide data on a new software and disposable tubing set upgrade of the Trima Accel® system version (V) 6.0 (Terumo BCT Inc., ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06602804?term=trima&viewType=Table&checkSpell=&rank=3

Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo ... The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the ...

4. withpower.com withpower.com/trial/phase-device-validation-of-in-vivo-performance-7-2024-b543a

Red Blood Cell Collection System Evaluation · Info for Participants The Trima Accel system has been shown to effectively collect blood components like red blood cells and platelets, ensuring high quality and safety for ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473050216301008

Effectiveness of the Trima Accel cell separator in ... The Trima Accel cell separator efficiently collected double dose platelets with median PLT yields of 3.7 × 1011, mean CE of 74.99 ± 14.40% and mean CR of 0.096 ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21951031&pc=GKT

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL Clotting was noted in the inlet line trap and draw/return pressure sensor.The reservoir was noted to be full of fluid with some blood in the ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=14114126&pc=GKT

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL Since this is a study which evaluated the impact of immediate adverse donation reactions on the return of volunteers undergoing platelet ...

8. healthycanadians.gc.ca healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33671r-eng.php

Trima Accel Automated Blood Collection System (April 24, 2013) There is the potential risk for an air embolism if air is delivered to a donor due to the failure mode of operator error in which the donor is ...