Evaluation of the AMICUS RBCx System in Sickle Cell Patients

Sickle Cell Anemia Clinical Trial

Official title:

Evaluation of the AMICUS Red Blood Cell Exchange (RBCx) System in Sickle Cell Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372877
• Other study ID #: AMIC-003-CMD
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: January 19, 2018

Study information

• Verified date: July 2022
• Source: Fenwal, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 19, 2018
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anemia

Intervention

Device:
• Amicus Red Cell Exchange in SCD patients
Each patient will be treated with one RBCx procedure using the AMICUS RBCx System

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	BloodCenter of Wisconsin	Milwaukee	Wisconsin
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Washington University	Saint Louis	Missouri

Sponsors (7)

Lead Sponsor	Collaborator
Fenwal, Inc.	Barbara Ann Karmanos Cancer Institute, Children's Hospital of Philadelphia, Phoenix Children's Hospital, University of Texas, Versiti, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR).	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.	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	Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit.	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.	Actual End Hematocrit will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Secondary	Subject Cell Loss Post-Procedure (WBC)	WBC loss post-procedure as measured with a complete blood count	Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Secondary	Serious Adverse Events	Evaluate the number of device related serious adverse events during the procedure and approximately 18-24 hours post-procedure.	During the procedure up to 24 hours post-procedure.
Secondary	Subject Cell Loss Post-Procedure (Platelets)	Platelet loss post-procedure as measured with a complete blood count	Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.