CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Algodrepdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04076683
NCT04076683N/ACompleted

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

Etablissement Français du Sang·interventional·Posted Sep 3, 2019·Updated Jan 26, 2024

In Brief

A clinical study evaluating Algodrep for Sickle Cell Disease. Completed, enrolled 65 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Martinique

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 3, 2019
Enrollment StartJan 5, 2022
Primary CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.8 years ago

Interventions

Algodrepdevice

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.