Evaluation of the AMICUS RBCx System in Sickle Cell Patients
- Conditions
- Sickle Cell Anemia
- Registration Number
- NCT02372877
- Lead Sponsor
- Fenwal, Inc.
- Brief 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.
- Detailed Description
The goal of Red Blood Cell Exchange is to remove a patient's red blood cells (RBCs) and replace the blood volume removed with either healthy donor RBCs and/or colloid/crystalloid solutions. Depending on the RF used, the procedure can be considered an RBC Exchange or RBC Depletion/Exchange procedure. The RBC Depletion/Exchange procedure is a modification of the RBC Exchange procedure. The AMICUS RBCx protocol provides the ability to use various RFs including healthy donor RBCs or a combination of fluids, such as saline followed by RBCs. In RBC Exchange and the exchange portion of the RBC Depletion/Exchange procedures, RBC units are used as the RF, while colloid and/or crystalloid solutions are used as the RF in the depletion portion of the RBC Depletion/Exchange procedures. A new operating protocol on the AMICUS Separator that enables the device to perform Red Blood Cell Exchange (RBCx) procedures in accordance with the replacement fluid(s) (RF) prescribed by a physician for patients with sickle cell disease
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR). Actual FCR will be assessed by taking a pre-procedure sample from the patient on the day of the procedure and a post-procedure sample approximately 10-15 min after procedure completion. The primary endpoint will evaluate the mean ratio of the Actual FCR (FCRa) to Target FCR (FCRt) as measured by the patient's Hb S pre-procedure and post-procedure. The predefined mean ratio of the FCRa to FCRt is 0.75 to 1.25.
- Secondary Outcome Measures
Name Time Method Subject Cell Loss Post-Procedure (WBC) Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion. WBC loss post-procedure as measured with a complete blood count
Subject Cell Loss Post-Procedure (Platelets) Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion. Platelet loss post-procedure as measured with a complete blood count
Serious Adverse Events During the procedure up to 24 hours post-procedure. Evaluate the number of device related serious adverse events during the procedure and approximately 18-24 hours post-procedure.
Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit. Actual End Hematocrit will be measured by taking a sample from the patient approximately 10-15 min after procedure completion. Evaluate the accuracy of subject hematocrit post-procedure (End Hematocrit) (as measured by the patient's hematocrit at the end of the procedure) compared to the target End Hematocrit.
Trial Locations
- Locations (6)
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Washington University
🇺🇸Saint 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
Phoenix Children's Hospital🇺🇸Phoenix, Arizona, United States