Evaluation of the AMICUS RBCx System in Sickle Cell Patients

Status Completed

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02372877
Study type	Interventional
Source	Fenwal, Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 2015
Completion date	January 19, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04134299` - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease	N/A
Completed	`NCT04581356` - Voxelotor Sickle Cell Exercise Study	Phase 4
Completed	`NCT02712346` - The Role of Endothelin-1 in Sickle Cell Disease	Phase 1
Completed	`NCT01976416` - Novel Use Of Hydroxyurea in an African Region With Malaria	Phase 3
Withdrawn	`NCT02162225` - Study of Beet Juice for Patients With Sickle Cell Anemia	Phase 2
Completed	`NCT01137721` - State Of The Art Functional Imaging In Sickle Cell Disease
Terminated	`NCT01350232` - Treatment of Sickle Cell Anemia With Stem Cell Transplant	N/A
Withdrawn	`NCT00937144` - Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil	Phase 4
Completed	`NCT00512564` - Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia	N/A
Completed	`NCT00512226` - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia	N/A
Completed	`NCT00004143` - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes	Phase 2
Completed	`NCT00004412` - Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Phase 2
Withdrawn	`NCT01925001` - Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis	Phase 2
Completed	`NCT01783990` - Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Completed	`NCT01848691` - Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis	N/A
Completed	`NCT01000155` - Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease	Phase 2
Completed	`NCT00874172` - Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy	N/A
Completed	`NCT00236093` - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain	Phase 2
Completed	`NCT00399074` - Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia	Phase 3
Completed	`NCT00004492` - Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia	Phase 1/Phase 2