Evaluation of the AMICUS RBCx System in Sickle Cell Patients

Completed · Not applicable

Conditions studied: Sickle Cell Anemia

In brief

The purpose of this study is to evaluate the performance of the AMICUS Red Blood Cell Exchange (RBCx) System (Exchange and Depletion/Exchange procedures) in patients with sickle cell disease.

Key facts

Study ID

NCT02372877

Run by

Fenwal, Inc.

People needed

83

Starts

2015-05-01

Expected to finish

2018-01-19

Last updated by the study team

2022-07-29

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with documented diagnosis of a type of sickle cell disorder who require RBC Exchange or RBC Depletion/Exchange treatment.
• Medically stable subjects who have been previously treated for sickle cell disease with RBC Exchange or RBC Depletion/Exchange.
• Subjects, or subject's legal representative, who have provided signed informed consent, and assent when applicable, prior to participation.
• Adequate availability of sickle trait negative, leukoreduced, Blood type (ABO) blood group, Rhesus factor D (Rh (D)) compatible, unexpired replacement RBC products.
• Subjects with sufficient vascular access to accommodate the RBCx procedure as determined by the medical staff responsible for obtaining intravenous access.
• Subjects who are able and agree to report adverse events (AEs) during the required reporting period.

You may not qualify if…

• Procedures that occur during acute hospitalization.
• Procedures prescribed within one week of discharge of a hospitalization.
• Subjects with altered mental status that would prohibit the giving and understanding of informed consent, and assent when applicable, who do not have a legally authorized representative.
• Drug abuse, alcohol abuse, or other factors that in the opinion of the investigator could affect the ability of the subject to comply with the requirements of the protocol.
• Subjects who have experienced a serious adverse event associated with an RBCx procedure in the past.
• In the opinion of the investigator, subjects who have a life expectancy fewer than 30 days.
• Subjects who refuse blood products.
• Subjects who are pregnant.
• Subjects who fail to comply with site requirements for cessation of medication that interfere or increase procedure risk.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• BloodCenter of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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