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

January 25, 2024 updated by: Etablissement Français du Sang

Validation d'Une Stratégie de Programme Transfusionnel Par Erythraphérèse basée Sur un Algorithme d'Aide à la Prescription Transfusionnelle Chez Les Patients Adultes Drépanocytaires

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Auvergne Rhône-Alpes
      • Saint-Priest-en-Jarez, Auvergne Rhône-Alpes, France, 42277
        • EFS Rhône-Alpes-Auvergne
        • Contact:
          • Christine AUBREGE-BOUVIER
          • Phone Number: +33 4 77 92 85 66
    • Bourgogne Franche-Comté
      • Besançon, Bourgogne Franche-Comté, France, 25000
        • Centre de Santé EFS
        • Contact:
          • Antoine CARPI
          • Phone Number: +33 3 81 61 56 15
    • Bretagne
      • Rennes, Bretagne, France, 35016
        • Centre de Santé EFS
        • Contact:
          • Cathy DUGOR
          • Phone Number: +33 2 23 22 53 95
    • Centre-Val De Loire
      • Tours, Centre-Val De Loire, France, 37206
        • Centre de Santé EFS
        • Contact:
          • Béatrice HERAULT
          • Phone Number: +33 2 47 36 01 14
    • Ile De France
      • Le Kremlin-Bicêtre, Ile De France, France, 94270
        • CHU Kremlin Bicêtre
        • Contact:
          • Christelle CHANTALAT
          • Phone Number: +33 1 45 21 71 10
    • Ile-de-France
      • Créteil, Ile-de-France, France, 94010
        • Hopital Henri Mondor
        • Contact:
          • Dehbia MENOUCHE
          • Phone Number: +33 1 49 81 42 49
    • Nouvelle-Aquitaine
      • Bordeaux, Nouvelle-Aquitaine, France, 33035
        • Centre de Santé EFS
        • Contact:
          • Florian THEVENOT
          • Phone Number: +33 5 56 90 82 03
  • Martinique
      • Le Lamentin, Martinique, 97232
        • CHU de Martinique
        • Contact:
          • Gylna LOKO
          • Phone Number: +33 5 96 48 81 89

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Algorithm (arm A)
Frequency and volume for apherisis proposed by algorithm and validated by the physician
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.
No Intervention: Usual care (arm C)
Frequency and volume for apherisis only decided by the physician (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with individually achieved objectives in terms of % HbS
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period

Secondary Outcome Measures

Outcome Measure
Time Frame
Volume of transfused RBCs
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Number of transfused RBCs
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Number of apherisis per participant
Time Frame: Over a 12 months period
Over a 12 months period
Hematocrit (percentage)
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Hemoglobin (g/dL)
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Number of reticulocyte (g/L),
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Percentage of reticulocyte
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Lactate dehydrogenase (UI/L)
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Creatinine (mg/L)
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Alanine aminotransferase (UI/L)
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Aspartate aminotransferase (UI/L)
Time Frame: For each apherisis over a 12 months period
For each apherisis over a 12 months period
Bilirubin T (mg/dL)
Time Frame: For each apherisis over a 12 months period
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
For each apherisis over a 12 months period
Quality of life questionnaire (SF-36)
Time Frame: At baseline and in 12 months
At baseline and in 12 months
Physician satisfaction survey for each participant
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Français du Sang

Collaborators

Assistance Publique - Hôpitaux de Paris
Université Paris Est Créteil

Investigators

  • Principal Investigator: Pablo BARTOLUCCI, Henri Mondor University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01411-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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