Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the AMICUS RBCx System in Sickle Cell Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372877
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
Versiti
Children's Hospital of Philadelphia
Barbara Ann Karmanos Cancer Institute
University of Texas
Washington University School of Medicine
Phoenix Children's Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Device: Amicus Red Cell Exchange in SCD patients Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the AMICUS Red Blood Cell Exchange (RBCx) System in Sickle Cell Patients
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : January 19, 2018


Arm Intervention/treatment
Experimental: Amicus Red Cell Exchange in SCD patients
Open arm. Patients with sickle cell disease (SCD) treated using one Amicus Red Cell Exchange procedure.
Device: Amicus Red Cell Exchange in SCD patients
Each patient will be treated with one RBCx procedure using the AMICUS RBCx System
Other Name: AMICUS RBCx System




Primary Outcome Measures :
  1. Evaluation of the accuracy of patient's actual fraction of original red blood cells remaining as measured by the patient's pre-procedure Hb S and post-procedure Hb S to the target Fraction of Cells Remaining (FCR). [ 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. ]
    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 :
  1. Evaluate the accuracy of patient's End Hematocrit as measured by the patient's post-procedure hematocrit. [ Time Frame: 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.

  2. Subject Cell Loss Post-Procedure [ Time Frame: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion. ]
    Evaluate patient cellular loss (white blood cells, platelets) post-procedure as measured with a complete blood count.

  3. Serious Adverse Events [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372877


Locations
Layout table for location information
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Wisconsin
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Fenwal, Inc.
Versiti
Children's Hospital of Philadelphia
Barbara Ann Karmanos Cancer Institute
University of Texas
Washington University School of Medicine
Phoenix Children's Hospital
Investigators
Layout table for investigator information
Study Chair: Paul Swerdlow, MD Barbara Ann Karmanos Cancer Institute
Layout table for additonal information
Responsible Party: Fenwal, Inc.
ClinicalTrials.gov Identifier: NCT02372877    
Other Study ID Numbers: AMIC-003-CMD
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fenwal, Inc.:
Sickle Cell Disease
Hemoglobin (Hb) S Disease
Hb S Disease
Congenital Hemolytic Anemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn