Clinical Trial: Evaluation of the AMICUS RBCx System in Sickle Cell Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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
Sponsor: Fenwal, Inc.

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Fenwal, Inc.

Dates:
Date Received: February 6, 2015
Date Started: May 2015
Date Completion: December 2016
Last Updated: January 22, 2016
Last Verified: January 2016