Sickle Cell AnemiaNCT02372877
Evaluation of the AMICUS RBCx System in Sickle Cell Patients
A study testing Amicus Red Cell Exchange in SCD patients in people with Sickle Cell Anemia, run by Fenwal, Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- Amicus Red Cell Exchange in SCD patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2015to 19 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
BloodCenter of Wisconsin
Milwaukee, Wisconsin, 53226
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Washington University
St Louis, Missouri, 63110
About this study
Official title: Evaluation of the AMICUS Red Blood Cell Exchange (RBCx) System in Sickle Cell Patients
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.
Read the 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
- Being tested
- Amicus Red Cell Exchange in SCD patients
- Keywords
- Sickle Cell Disease, Hemoglobin (Hb) S Disease, Hb S Disease, Congenital Hemolytic Anemia
- Medical subject headings
- Anemia, Sickle Cell, Anemia, Hemolytic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amicus Red Cell Exchange in SCD patientsDevice
Also called AMICUS RBCx System
Each patient will be treated with one RBCx procedure using the AMICUS RBCx System
| Study group | Role | What they receive |
|---|---|---|
| Amicus Red Cell Exchange in SCD patients | Experimental | Open arm. Patients with sickle cell disease (SCD) treated using one Amicus Red Cell Exchange procedure. Receives: Device: Amicus Red Cell Exchange in SCD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR).
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.
Measured: 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.
Secondary outcomes (4)
Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit.
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.
Measured: Actual End Hematocrit will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Subject Cell Loss Post-Procedure (WBC)
WBC loss post-procedure as measured with a complete blood count
Measured: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Serious Adverse Events
Evaluate the number of device related serious adverse events during the procedure and approximately 18-24 hours post-procedure.
Measured: During the procedure up to 24 hours post-procedure.
Subject Cell Loss Post-Procedure (Platelets)
Platelet loss post-procedure as measured with a complete blood count
Measured: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion7 Dec 2017
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenwal, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Versiti Blood Health, Children's Hospital of Philadelphia, Barbara Ann Karmanos Cancer Institute, University of Texas, Washington University School of Medicine, Phoenix Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Paul Swerdlow, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372877
- Sponsor's protocol ID
- AMIC-003-CMD
- Status last verified
- Jul 2022
- First submitted
- 6 Feb 2015
- Last updated
- 29 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the AMICUS Red Blood Cell Exchange (RBCx) System in Sickle Cell Patients
- ClinicalTrials.gov ID
- NCT02372877
- Acronym / sponsor ID
- AMIC-003-CMD
- Conditions
- Sickle Cell Anemia
- Keywords
- Sickle Cell Disease, Hemoglobin (Hb) S Disease, Hb S Disease, Congenital Hemolytic Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Fenwal, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Versiti Blood Health, Children's Hospital of Philadelphia, Barbara Ann Karmanos Cancer Institute, University of Texas, Washington University School of Medicine, Phoenix Children's Hospital
- Study start
- May 2015 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 29 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amicus Red Cell Exchange in SCD patients | Experimental | Device: Amicus Red Cell Exchange in SCD patientsOpen arm. Patients with sickle cell disease (SCD) treated using one Amicus Red Cell Exchange procedure. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amicus Red Cell Exchange in SCD patientsAlso: AMICUS RBCx SystemEach patient will be treated with one RBCx procedure using the AMICUS RBCx System | Device | Amicus Red Cell Exchange in SCD patients |
Primary outcome
Actual Fraction of Original Red Blood Cells Remaining 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.
4 secondary outcomes
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.
Subject Cell Loss Post-Procedure (WBC)
Time frame: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Serious Adverse Events
Time frame: During the procedure up to 24 hours post-procedure.
Subject Cell Loss Post-Procedure (Platelets)
Time frame: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Swerdlow, MD study chair
Barbara Ann Karmanos Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amicus Red Cell Exchange in SCD patients in people with Sickle Cell Anemia, run by Fenwal, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual Fraction of Original Red Blood Cells Remaining 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.