Evaluation of the AMICUS RBCx System in Sickle Cell Patients
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|ClinicalTrials.gov Identifier: NCT02372877|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Anemia||Device: Amicus Red Cell Exchange in SCD patients||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|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|
|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|
|Study Chair:||Paul Swerdlow, MD||Barbara Ann Karmanos Cancer Institute|