N/A
Completed N=83
Evaluation of the AMICUS RBCx System in Sickle Cell Patients
Source: ClinicalTrials.gov NCT02372877 ↗Enrolled (actual)
83
Serious AEs
2.4%
Results posted
Jul 2022
Primary outcomePrimary: Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR). — 0.978 Ratio
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR). |
0.978 | — |
| SECONDARY Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit. |
1.19 | — |
| SECONDARY Subject Cell Loss Post-Procedure (WBC) |
27.414 | — |
| SECONDARY Serious Adverse Events |
— | — |
| SECONDARY Subject Cell Loss Post-Procedure (Platelets) |
48.967 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02372877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.