Fact CheckerSign in

NCT04076683Completed

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

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

Source: ClinicalTrials.gov · Last updated 26 Jan 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
65 (actual)
First submitted
26 Aug 2019
Start date
5 Jan 2022
Primary completion date
30 Nov 2023
Lead sponsor
Etablissement Français du Sang
NCT number
NCT04076683

What you commit to

  • Study type: Interventional
  • Participants enrolled: 65
  • From 5 Jan 2022 to the primary completion date, 30 Nov 2023
  • 8 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving EPO treatment

Other illness

  • Have sickle cell disease defined with S-β+thal

Age

  • Lack of effective contraception in women in childbearing age

Other

  • Pregnant or breast-feeding women
  • Patient under guardianship

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre de Santé EFS
Coordinator of this site? Confirm its status
BesançonFranceUnknown status
Centre de Santé EFS
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
Hopital Henri Mondor
Coordinator of this site? Confirm its status
CréteilFranceUnknown status
CHU Kremlin Bicêtre
Coordinator of this site? Confirm its status
Le Kremlin-BicêtreFranceUnknown status
Centre de Santé EFS
Coordinator of this site? Confirm its status
RennesFranceUnknown status
EFS Rhône-Alpes-Auvergne
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceUnknown status
Centre de Santé EFS
Coordinator of this site? Confirm its status
ToursFranceUnknown status
CHU de Martinique
Coordinator of this site? Confirm its status
Le LamentinMartiniqueUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.