Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Algorithm for Apherisis Monitoring and Prescription Assistance in Sickle Cell Patients (ALGODREP) (ALGODREP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04076683
Recruitment Status : Unknown
Verified August 2019 by Etablissement Français du Sang.
Recruitment status was:  Not yet recruiting
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
Université Paris Est Créteil
Information provided by (Responsible Party):
Etablissement Français du Sang

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE September 3, 2019
Last Update Posted Date September 3, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
Number of patients with individually achieved objectives in terms of % HbS [ Time Frame: For each apherisis over a 12 months period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
  • Volume of transfused RBCs [ Time Frame: For each apherisis over a 12 months period ]
  • Number of transfused RBCs [ Time Frame: For each apherisis over a 12 months period ]
  • Number of apherisis per participant [ Time Frame: Over a 12 months period ]
  • Hematocrit (percentage) [ Time Frame: For each apherisis over a 12 months period ]
  • Hemoglobin (g/dL) [ Time Frame: For each apherisis over a 12 months period ]
  • Number of reticulocyte (g/L), [ Time Frame: For each apherisis over a 12 months period ]
  • Percentage of reticulocyte [ Time Frame: For each apherisis over a 12 months period ]
  • Lactate dehydrogenase (UI/L) [ Time Frame: For each apherisis over a 12 months period ]
  • Creatinine (mg/L) [ Time Frame: For each apherisis over a 12 months period ]
  • Alanine aminotransferase (UI/L) [ Time Frame: For each apherisis over a 12 months period ]
  • Aspartate aminotransferase (UI/L) [ Time Frame: For each apherisis over a 12 months period ]
  • Bilirubin T (mg/dL) [ Time Frame: For each apherisis over a 12 months period ]
  • Percentage of alloimmunisation events evaluated with irregular red cell antibodies measure [ Time Frame: For each apherisis over a 12 months period ]
  • Quality of life questionnaire (SF-36) [ Time Frame: At baseline and in 12 months ]
  • Physician satisfaction survey for each participant [ Time Frame: Month 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Algorithm for Apherisis Monitoring and Prescription Assistance in Sickle Cell Patients (ALGODREP)
Official Title  ICMJE Validation d'Une Stratégie de Programme Transfusionnel Par Erythraphérèse basée Sur un Algorithme d'Aide à la Prescription Transfusionnelle Chez Les Patients Adultes Drépanocytaires
Brief Summary

The main objective of this study is to prove the superiority of a procedure which calculates the volume of RBCs to transfuse and the time between apheresis based on this algorithm, compared to the current procedure. The primary endpoint would be the number of patients with individually achieved objectives in terms of % HbS before each apheresis (which reflects the effectiveness of the previous apheresis) over a period of 12 months. The secondary objectives would be to compare the volume differences of transfused RBCs in both groups over a period of 12 months, the occurrence of clinical events and the satisfaction of patients and physicians.

The investigators hope that this study would improve the efficiency and the performance of apheresis in sickle cell patients. The investigators also hope to facilitate the organization of procedures with the flexibility that would allow the use of this algorithm.

Detailed Description

Sickle cell disease (SCD) is the most common genetic disease leading to abnormal hemoglobin (HbS). Chronic complications can be severe and affect multiple organs. Among them, cerebrovascular disease is one of the most serious leading to a high risk of stroke. These complications often require blood exchange transfusions (BET) in order to replace red blood cells (RBC) containing HbS (from patients) by GR containing HbA (blood donors), and thereby stop the harmful pathophysiological cascade. The indications of long-term apheresis are mostly, but not exclusively, represented by cerebral vasculopathy (85% in our center), and chronic organ damages. Long-term BET in cerebral vasculopathy may considerably reduce the risk of stroke while stopping them leads to a recurrence of this risk, hence there is a need to do them regularly (on average every 4 to 6 weeks) with an objective of HbS ≤ 30%. This objective may be less stringent in the case of other indications.

Two methods are used: a manual method which is feasible anywhere and the apheresis which is preferred because of its better efficacy in achieving the targets of HbS percentage. It also limits transfusion hemochromatosis.

The volume required for BET by apheresis as well as the optimal period between apheresis sessions are empirically determined.

In our practice, the investigators noticed that this method did not allow to steadily obtaining the %HbS objective and the interval between apheresis was variable, in part conditioned by the availability of machines. This implies a real risk of occurrence of recurrent stroke in patients with cerebral vascular disease and may cause a lack of flexibility in the timing of appointments.

Thereby the principal investigator and the biostatistician created an algorithm to compute the volume of blood to be transfused and the interval between apheresis which are necessary to maintain an individual objective of HbS percentage. This algorithm has been obtained by statistical analysis of apheresis performed at Henri Mondor Hospital over a period of 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Device: Algodrep
Algorithm computing the volume of blood to be transfused and the interval between apheresis which are necessary to maintain an individual objective of HbS percentage.
Study Arms  ICMJE
  • Experimental: Algorithm (arm A)
    Frequency and volume for apherisis proposed by algorithm and validated by the physician
    Intervention: Device: Algodrep
  • No Intervention: Usual care (arm C)
    Frequency and volume for apherisis only decided by the physician (usual care)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 30, 2019)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or older
  • Have sickle cell disease, defined as those individuals with HbSS or HbSβ0Thal
  • Included in a Blood Exchange Transfusion program (apherisis)
  • Benefiting from social insurance
  • Accepting to participate in the study and having signed the informed consent

Exclusion Criteria:

  • Have sickle cell disease defined with S-β+thal
  • Receiving EPO treatment
  • Pregnant or breast-feeding women
  • Lack of effective contraception in women in childbearing age
  • Patient under guardianship
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Martinique
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04076683
Other Study ID Numbers  ICMJE 2016-A01411-50
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Etablissement Français du Sang
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Etablissement Français du Sang
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Assistance Publique - Hôpitaux de Paris
  • Université Paris Est Créteil
Investigators  ICMJE
Principal Investigator: Pablo BARTOLUCCI Henri Mondor University Hospital
PRS Account Etablissement Français du Sang
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP