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Evaluation of the AMICUS RBCx System in Sickle Cell Patients

Primary Purpose

Sickle Cell Anemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amicus Red Cell Exchange in SCD patients
Sponsored by
Fenwal, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Anemia focused on measuring Sickle Cell Disease, Hemoglobin (Hb) S Disease, Hb S Disease, Congenital Hemolytic Anemia

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Children's Hospital
  • Barbara Ann Karmanos Cancer Institute
  • Washington University
  • The Children's Hospital of Philadelphia
  • University of Texas Southwestern Medical Center
  • BloodCenter of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amicus Red Cell Exchange in SCD patients

Arm Description

Open arm. Patients with sickle cell disease (SCD) treated using one Amicus Red Cell Exchange procedure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Subject Cell Loss Post-Procedure (WBC)
WBC loss post-procedure as measured with a complete blood count
Serious Adverse Events
Evaluate the number of device related serious adverse events during the procedure and approximately 18-24 hours post-procedure.
Subject Cell Loss Post-Procedure (Platelets)
Platelet loss post-procedure as measured with a complete blood count

Full Information

First Posted
February 6, 2015
Last Updated
July 7, 2022
Sponsor
Fenwal, Inc.
Collaborators
Versiti, Children's Hospital of Philadelphia, Barbara Ann Karmanos Cancer Institute, University of Texas, Washington University School of Medicine, Phoenix Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02372877
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
January 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fenwal, Inc.
Collaborators
Versiti, Children's Hospital of Philadelphia, Barbara Ann Karmanos Cancer Institute, University of Texas, Washington University School of Medicine, Phoenix Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia
Keywords
Sickle Cell Disease, Hemoglobin (Hb) S Disease, Hb S Disease, Congenital Hemolytic Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amicus Red Cell Exchange in SCD patients
Arm Type
Experimental
Arm Description
Open arm. Patients with sickle cell disease (SCD) treated using one Amicus Red Cell Exchange procedure.
Intervention Type
Device
Intervention Name(s)
Amicus Red Cell Exchange in SCD patients
Other Intervention Name(s)
AMICUS RBCx System
Intervention Description
Each patient will be treated with one RBCx procedure using the AMICUS RBCx System
Primary Outcome Measure Information:
Title
Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR).
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit.
Description
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.
Time Frame
Actual End Hematocrit will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Title
Subject Cell Loss Post-Procedure (WBC)
Description
WBC loss post-procedure as measured with a complete blood count
Time Frame
Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Title
Serious Adverse Events
Description
Evaluate the number of device related serious adverse events during the procedure and approximately 18-24 hours post-procedure.
Time Frame
During the procedure up to 24 hours post-procedure.
Title
Subject Cell Loss Post-Procedure (Platelets)
Description
Platelet loss post-procedure as measured with a complete blood count
Time Frame
Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Swerdlow, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
BloodCenter of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of the AMICUS RBCx System in Sickle Cell Patients

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