Clinical trial NCT02372877: Evaluation of the AMICUS RBCx System in Sickle Cell Patients
Official title: Evaluation of the AMICUS Red Blood Cell Exchange (RBCx) System in Sickle Cell Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Anemia
Keywords: Sickle Cell Disease
Hemoglobin (Hb) S Disease
Hb S Disease
Congenital Hemolytic Anemia
Lead sponsor: Fenwal, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Versiti
name: Children's Hospital of Philadelphia
name: Barbara Ann Karmanos Cancer Institute
name: University of Texas
name: Washington University School of Medicine
name: Phoenix Children's Hospital
First posted: 2015-02-26
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR).
timeFrame: 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.
Secondary outcomes:
measure: Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit.
timeFrame: Actual End Hematocrit will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
measure: Subject Cell Loss Post-Procedure (WBC)
timeFrame: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
measure: Serious Adverse Events
timeFrame: During the procedure up to 24 hours post-procedure.
measure: Subject Cell Loss Post-Procedure (Platelets)
timeFrame: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Milwaukee
country: United States
facility: BloodCenter of Wisconsin
state: Wisconsin
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Paul Swerdlow, MD
role: STUDY_CHAIR
References: