NCT02372877

Evaluation of the AMICUS RBCx System in Sickle Cell Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Fenwal, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sickle Cell Anemia

Interventions

Type	Name	Description
DEVICE	Amicus Red Cell Exchange in SCD patients	Each patient will be treated with one RBCx procedure using the AMICUS RBCx System

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-12-07
• Completion: 2018-01-19
• First posted: 2015-02-26
• Last updated: 2022-07-29
• Results posted: 2022-07-29

Locations

6 sites across 1 country: United States