CompletedNot Applicable

Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study

United States37 participantsStarted 2024-08-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Given written informed consent.
✓. Age 18 years or older.
✓. Normal health status as per AABB criteria for healthy donor.
✓. Able to commit to the study schedule.
✓. Meets the inclusion criteria defined by site SOPs for automated blood component collection systems or whole blood donation. These criteria are based on AABB standards and FDA regulations.
✓. Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study.
✓. Female participants of childbearing potential must agree to take a pregnancy test prior to the apheresis procedure and prior to reinfusion of radiolabeled LR-RBCs.
✓. Participants must agree to report AEs throughout their participation in the study

Exclusion criteria

✕. Currently pregnant or nursing females.
✕. Serum ferritin less than12 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).
✕. As determined by the Investigator:
✕. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency \[G6PD\]),
✕. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies,
✕. Clinically significant acute or chronic disease, or

What they're measuring

Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)

Timeframe: 43 days

Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method)

Timeframe: 43 days

Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method)

Timeframe: 43 days

Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method)

Timeframe: 43 days

Trial details

NCT IDNCT06602804

SponsorTerumo BCT

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-31

Results submitted2026-01-29

View on ClinicalTrials.gov More Device Validation of In-vivo Performance trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Given written informed consent.
✓. Age 18 years or older.
✓. Normal health status as per AABB criteria for healthy donor.
✓. Able to commit to the study schedule.
✓. Meets the inclusion criteria defined by site SOPs for automated blood component collection systems or whole blood donation. These criteria are based on AABB standards and FDA regulations.
✓. Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study.
✓. Female participants of childbearing potential must agree to take a pregnancy test prior to the apheresis procedure and prior to reinfusion of radiolabeled LR-RBCs.
✓. Participants must agree to report AEs throughout their participation in the study

Exclusion criteria

✕. Currently pregnant or nursing females.
✕. Serum ferritin less than12 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).
✕. As determined by the Investigator:
✕. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency \[G6PD\]),
✕. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies,
✕. Clinically significant acute or chronic disease, or

What they're measuring

Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)

Timeframe: 43 days

Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method)

Timeframe: 43 days

Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method)

Timeframe: 43 days

Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method)

Timeframe: 43 days