Study of INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS)

Overview

About this study

Stage A: To evaluate the safety and efficacy of the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in adult patients who require RBC transfusion support. Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in regions where a substantial proportion of the population has been infected or is at risk of infection by the Zika virus (ZIKV), and the risk of asymptomatic infection among qualified blood donors is recognized. Besides the reduction of risk of transfusion transmitted ZIKV, the intent of the study is also to reduce the risk of transfusion-transmitted infections (TTI) in general, including transfusion related sepsis and other emerging or concurrent endemic pathogens (e.g. Dengue and Chikungunya), and to reduce the risk of TA-GVHD. As part of this treatment use study, additional data will be provided on the safety of INTERCEPT-treated RBCs (IBS RBCs) supplied for routine clinical transfusion practice.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Stage A

  • Age ≥ 18 years old.
  • Patients who require or are expected to require a transfusion of RBC component(s), including red cell exchange transfusion.
  • Signed and dated informed consent.
  • Female patients of child-bearing potential must:
    • Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy; and
    • Use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation and an additional 28 days.

Stage B

  • Age ≥ 11 years old.
  • Patients expected to require or requiring a transfusion of RBC component(s), including red cell exchange transfusion.
  • Signed and dated informed consent and assent (if applicable).
  • Female patients of child-bearing potential must:
    • Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy; and
    • Use at least one method of birth control that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation and an additional 28 days.

Exclusion Criteria:

Stage A

  • Confirmed positive baseline serum/plasma antibody specific to IBS RBC (S-303 treated RBC) as determined by INTERCEPT antibody screening panel prior to receiving the first study transfusion.
  • Pregnant or breast feeding.
  • Presence of a RBC warm autoantibody.
  • Positive DAT as defined below:
    • A polyspecific-DAT reaction strength > 2+; or
    • A polyspecific-DAT (any strength) in conjunction with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody.
  • Have had an RBC transfusion within 14 days prior to S-303 antibody screen for eligibility.
  • Have received investigational products, including investigational blood products, pharmacologic agents or imaging materials, within the prior 28 days. Prior receipt of conventional blood products tested with an investigational ZIKV NAT test are not considered grounds for exclusion despite the investigational nature of the NAT test.
  • Patients presenting with or expected to have massive hemorrhage (≥ 10 RBC units within 24 hours) or expected to require massive transfusion protocols. Planned red cell exchange does not apply.
  • Patients who require neonatal transfusions and intrauterine transfusions.
  • Pre-existing antibody to RBC antigens that may make the provision of compatible study RBC components difficult.
  • History of transfusion reactions requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.
  • Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.

Stage B

  • Confirmed positive baseline serum/plasma antibody specific to IBS RBC as determined by antibody screening panel to S-303 treated RBC prior to receiving their first study transfusion.
  • Pregnant or breast feeding.
  • Patients who require neonatal transfusions and intrauterine transfusions.
  • Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
  • Pre-existing antibody to RBC antigens that may make the provision of compatible study RBC components difficult.
  • History of transfusion reactions requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Abba Zubair, M.D., Ph.D.

Open for enrollment

Contact information:

Katelyn Register M.S., C.C.R.C.

Register.Katelyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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