Age of Blood in Sickle Cell Transfusion

NCT03704922 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 21-0018K23HL136787-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

The Investigators hypothesize that older red cell units trigger phagocytosis and activation of circulating macrophages with a downstream immunomodulatory cascade and release of excess Non Transferrin Bound Iron(NTBI) that leads to increased rates of infection in adults with Sickle Cell Disease(SCD). To test this hypothesis, the study staff will perform a randomized prospective clinical trial. In aim 1, the study staff will determine the biochemical differences between ≥30 day-old versus ≤10 day-old units. In aim 2, the study staff will determine the physiologic effects of the transfused blood in a patient with SCD. Lastly, in aim 3, the study staff will explore the clinical implications of receiving older red cells over a 3 month period.

Conditions

Sickle Cell Disease

Keywords

Transfusion

Outcome Measures

Primary Outcomes (1)

• Proportion of Biochemically Old Red Cell Units

  The investigators will compare the transfusions provided to the two groups (the proportion of biochemically old units when stored ≥30 days compared to when stored ≤10 days) using a Fisher exact test at an alpha of 0.05.

  through third transfusion, an average of 18 weeks

Other Outcomes (2)

• Change in the Concentration of CD62L Positive Circulating Monocytes

  through third transfusion, an average of 18 weeks

• Percentage of Infections in Adults

  through fourth transfusion, an average of 24 weeks

Study Arms (2)

≤10 day Blood

EXPERIMENTAL

Subjects in this group will receive only blood stored ≤10 days for 3 consecutive transfusion events.

Biological: Transfusion

≥30 day Blood

EXPERIMENTAL

Subjects in this group will receive only blood stored ≥30 days for 3 consecutive transfusion events.

Biological: Transfusion

Interventions

Transfusion BIOLOGICAL

Red cell units for transfusion

≤10 day Blood; ≥30 day Blood

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 16 to 60 years
• have diagnosis of sickle cell disease
• receiving outpatient red cell transfusion therapy
• outpatient at the time of transfusion

You may not qualify if:

• history of reactions to transfusion therapy that cannot be adequately managed by antihistamines
• do not have crossmatch compatible red cells
• participation in another therapeutic trial for SCD
• pregnant
• HIV positive
• uncontrolled inter-current illness, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Versiti Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• Karafin MS, Fasano RM, Ilich A, Wichlan D, Chang A, Janecke R, Zellner-Jones S, James SM, Butler HE, Kolupaev O, Caughey MC, Wilson SR, Key NS, Field JJ, Little JA. Red cell physiologic stress results in lower quality transfusions: a randomized trial in adults with sickle cell disease. Blood Red Cells Iron. 2025 Dec;1(3):100017. doi: 10.1016/j.brci.2025.100017. Epub 2025 Oct 1.

  PMID: 41312340 DERIVED

• Karafin MS, Grier AL, Fasano RM, Ilich A, Wichlan D, Chang A, James SM, Butler HE, Kolupaev O, Caughey MC, Stephenson DJ, Reisz JA, Key NS, Field JJ, Little JA, Spitalnik SL, D'Alessandro A. Blood-storage duration affects hematological and metabolic profiles in patients with sickle cell disease receiving transfusions. J Clin Invest. 2025 Jul 3;135(17):e192920. doi: 10.1172/JCI192920. eCollection 2025 Sep 2.

  PMID: 40608427 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Matthew S. Karafin MD MS
• Organization: University of North Carolina at Chapel Hill

matthew.Karafin@unchealth.unc.edu

984-974-1583

Study Officials

• Jane Little, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Matthew Karafin, MD, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 15, 2018
• Study Start: October 4, 2017
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 to 36 months following publication
• Access Criteria: IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.

Locations

US (3)