Recovery and Lifespan of Red Blood Cells From Pathogen-reduced, Stored Blood Units

NCT03384407 | Unknown FDA Device

• 1 other identifier: 2018-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot study has two objectives: 1) to assess the post-infusion viability of INTERCEPT RBC by measuring the 24 hour post-infusion recovery ("PTR24") and lifespan of autologous RBCs prepared with the INTERCEPT System for RBC after storage for 35 days under standard blood banking conditions using two different RBC labels; 51-chromium and biotin. The control will be conventional untreated RBCs stored for 35 days; and 2) comparison and contrast of PTR24 and lifespan results of the 51-chromium and biotin labeling methods of RBC stored for 35 days under standard blood banking conditions. The purpose of gathering these data is to obtain more meaningful survival data for stored conventional and INTERCEPT RBCs over the entire 120 d RBC lifespan (51-Cr labeled RBC permits a maximum 28 d assessment as a result of 51-Cr's variable, progressive elution from RBC and radioactive half-life).

Conditions

Red Cell Survival in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 24 hour post-infusion recovery of autologous RBC stored in AS-5 for 35 days and then labeled with either 51Cr or biotin.

  24 hours

Secondary Outcomes (3)

• Mean lifespan of autologous RBC stored for 35 days and then labeled with either 51Cr or biotin

  days 37, 38, 42, 49, 56, 63, 77, 91, 105, 119, 133 and 147

• Median lifespan (T50) of autologous RBC stored for 35 days and then labeled with either 51Cr or biotin

  days 37, 38, 42, 49, 56, 63, 77, 91, 105, 119, 133 and 147

• Area under the curve (AUC) determined using data points collected for RBC lifespan of autologous, radiolabeled or BioRBCs

  days 37, 38, 42, 49, 56, 63, 77, 91, 105, 119, 133 and 147

Study Arms (1)

Open label

EXPERIMENTAL

Red cell recovery/survival analysis of untreated and INTERCEPT treated RBC concomitantly

Device: Red cell survival in INTERCEPT treated red cells

Interventions

Red cell survival in INTERCEPT treated red cells DEVICE

Red cell recovery/survival analysis of untreated and INTERCEPT treated RBC concomitantly

Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Up to 12 subjects will be enrolled for a maximum of 6 eligible subjects in the pilot study to provide preliminary RBC survival data to support a subsequent adequately powered study capable of addressing the two objectives as stated above.
• Age ≥18 years, of either gender
• Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
• Weight over 140 lbs.
• Complete blood count (CBC; including RBC indices MCV, MCH, MCHC, and RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, LDH, ALT, AST,total bilirubin, BUN, creatinine). Values outside of normal reference range if considered not to be clinically significant may be allowed with a protocol exception.
• Minimum hemoglobin levels of 13 g/dL for female and 14 g/dL for male subjects
• Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, WNV and Zika virus
• Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
• Meet or exceed AABB guidelines for blood donation (with the exception of travel deferrals).
• Signed and dated informed consent form

You may not qualify if:

• Clinically significant acute or chronic disease (as determined by the Investigator)
• History of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies or autoimmune disease
• History of congenital red cell disorders including glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Positive Direct (DAT) and Indirect antiglobulin test (IAT)at study entry
• Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
• Treatment with any medication known to affect RBC viability
• Pregnant or nursing female
• Male subjects or female subjects of childbearing potential not using effective contraception
• Participation in another clinical study currently or within the past 28 days
• Prior exposure to INTERCEPT treated or BioRBCs
• Pre-existing antibody specific to INTERCEPT RBCs or BioRBC
• Subjects are excluded if receiving immunosuppressive therapies (e.g., oral or intravenous corticosteroids) due to their potential to obscure immunogenicity or immunoreactivity to Test RBCs.
• Subjects donating blood for any other purpose
• Subjects who have received blood transfusion within the previous year
• Subjects who are enrolled in another study.

Sponsors & Collaborators

• University of Cincinnati: lead
• Cerus Corporation: collaborator
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

RECRUITING

Central Study Contacts

Jose A Cancelas, MD, PhD

CONTACT

513-558-1324; jose.cancelas@uc.edu

Neeta Rugg, MS

CONTACT

513-558-1525; neeta.rugg@uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Research Division Director, Hoxworth Blood Center

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 27, 2017
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

US (1)