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

NCT04076683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-01-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Paris 12 Val de Marne University

    collaborator OTHER

  • Etablissement Français du Sang

    lead OTHER

Principal Investigators

  • Pablo BARTOLUCCI · Henri Mondor University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • France
  • Martinique

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04076683 on ClinicalTrials.gov