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

NCT04076683 | Completed DMC

• 1 other identifier: 2016-A01411-50
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 8

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.

Conditions

Sickle Cell Disease

Keywords

Algorithm; Apherisis; Sickle cell patients

Outcome Measures

Primary Outcomes (1)

• Number of patients with individually achieved objectives in terms of % HbS

  For each apherisis over a 12 months period

Secondary Outcomes (15)

• Volume of transfused RBCs

  For each apherisis over a 12 months period

• Number of transfused RBCs

  For each apherisis over a 12 months period

• Number of apherisis per participant

  Over a 12 months period

• Hematocrit (percentage)

  For each apherisis over a 12 months period

• Hemoglobin (g/dL)

  For each apherisis over a 12 months period

Study Arms (2)

Algorithm (arm A)

EXPERIMENTAL

Frequency and volume for apherisis proposed by algorithm and validated by the physician

Device: Algodrep

Usual care (arm C)

NO INTERVENTION

Frequency and volume for apherisis only decided by the physician (usual care)

Interventions

Algodrep DEVICE

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.

Algorithm (arm A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Etablissement Français du Sang: lead
• Assistance Publique - Hôpitaux de Paris: collaborator
• Paris 12 Val de Marne University: collaborator

Study Sites (8)

EFS Rhône-Alpes-Auvergne

Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42277, France

Location

Centre de Santé EFS

Besançon, Bourgogne-Franche-Comté, 25000, France

Location

Centre de Santé EFS

Rennes, Brittany Region, 35016, France

Location

Centre de Santé EFS

Tours, Centre-Val de Loire, 37206, France

Location

Centre de Santé EFS

Bordeaux, Nouvelle-Aquitaine, 33035, France

Location

Hôpital Henri Mondor

Créteil, Île-de-France Region, 94010, France

Location

CHU Kremlin Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

Location

CHU de Martinique

Le Lamentin, 97232, Martinique

Location

Related Publications (15)

• Quinn CT, Ahmad N. Clinical correlates of steady-state oxyhaemoglobin desaturation in children who have sickle cell disease. Br J Haematol. 2005 Oct;131(1):129-34. doi: 10.1111/j.1365-2141.2005.05738.x.

  PMID: 16173973 BACKGROUND

• Quinn CT, Sargent JW. Daytime steady-state haemoglobin desaturation is a risk factor for overt stroke in children with sickle cell anaemia. Br J Haematol. 2008 Feb;140(3):336-9. doi: 10.1111/j.1365-2141.2007.06927.x. Epub 2007 Nov 27.

  PMID: 18042265 BACKGROUND

• Setty BN, Stuart MJ, Dampier C, Brodecki D, Allen JL. Hypoxaemia in sickle cell disease: biomarker modulation and relevance to pathophysiology. Lancet. 2003 Nov 1;362(9394):1450-5. doi: 10.1016/S0140-6736(03)14689-2.

  PMID: 14602439 BACKGROUND

• Nahavandi M, Nichols JP, Hassan M, Gandjbakhche A, Kato GJ. Near-infrared spectra absorbance of blood from sickle cell patients and normal individuals. Hematology. 2009 Feb;14(1):46-8. doi: 10.1179/102453309X385133.

  PMID: 19154664 BACKGROUND

• Nahavandi M, Tavakkoli F, Hasan SP, Wyche MQ, Castro O. Cerebral oximetry in patients with sickle cell disease. Eur J Clin Invest. 2004 Feb;34(2):143-8. doi: 10.1111/j.1365-2362.2004.01307.x.

  PMID: 14764078 BACKGROUND

• Waltz X, Pichon A, Lemonne N, Mougenel D, Lalanne-Mistrih ML, Lamarre Y, Tarer V, Tressieres B, Etienne-Julan M, Hardy-Dessources MD, Hue O, Connes P. Normal muscle oxygen consumption and fatigability in sickle cell patients despite reduced microvascular oxygenation and hemorheological abnormalities. PLoS One. 2012;7(12):e52471. doi: 10.1371/journal.pone.0052471. Epub 2012 Dec 20.

  PMID: 23285055 BACKGROUND

• Waltz X, Pichon A, Mougenel D, Lemonne N, Lalanne-Mistrih ML, Sinnapah S, Tarer V, Tressieres B, Lamarre Y, Etienne-Julan M, Hue O, Hardy-Dessources MD, Connes P. Hemorheological alterations, decreased cerebral microvascular oxygenation and cerebral vasomotion compensation in sickle cell patients. Am J Hematol. 2012 Dec;87(12):1070-3. doi: 10.1002/ajh.23318. Epub 2012 Aug 22.

  PMID: 22911571 BACKGROUND

• Belcher JD, Chen C, Nguyen J, Milbauer L, Abdulla F, Alayash AI, Smith A, Nath KA, Hebbel RP, Vercellotti GM. Heme triggers TLR4 signaling leading to endothelial cell activation and vaso-occlusion in murine sickle cell disease. Blood. 2014 Jan 16;123(3):377-90. doi: 10.1182/blood-2013-04-495887. Epub 2013 Nov 25.

  PMID: 24277079 BACKGROUND

• Eltzschig HK, Carmeliet P. Hypoxia and inflammation. N Engl J Med. 2011 Feb 17;364(7):656-65. doi: 10.1056/NEJMra0910283. No abstract available.

  PMID: 21323543 BACKGROUND

• Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.

  PMID: 22064429 BACKGROUND

• Lionnet F, Arlet JB, Bartolucci P, Habibi A, Ribeil JA, Stankovic K; groupe de recommandations et d'etude de la drepanocytose de l'adulte (GREDA). [Guidelines for management of adult sickle cell disease]. Rev Med Interne. 2009 Sep;30 Suppl 3:S162-223. doi: 10.1016/j.revmed.2009.07.001. Epub 2009 Aug 26. French.

  PMID: 19713011 BACKGROUND

• Adams RJ, McKie VC, Hsu L, Files B, Vichinsky E, Pegelow C, Abboud M, Gallagher D, Kutlar A, Nichols FT, Bonds DR, Brambilla D. Prevention of a first stroke by transfusions in children with sickle cell anemia and abnormal results on transcranial Doppler ultrasonography. N Engl J Med. 1998 Jul 2;339(1):5-11. doi: 10.1056/NEJM199807023390102.

  PMID: 9647873 BACKGROUND

• Adams RJ, Brambilla D; Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) Trial Investigators. Discontinuing prophylactic transfusions used to prevent stroke in sickle cell disease. N Engl J Med. 2005 Dec 29;353(26):2769-78. doi: 10.1056/NEJMoa050460.

  PMID: 16382063 BACKGROUND

• Abboud MR, Yim E, Musallam KM, Adams RJ; STOP II Study Investigators. Discontinuing prophylactic transfusions increases the risk of silent brain infarction in children with sickle cell disease: data from STOP II. Blood. 2011 Jul 28;118(4):894-8. doi: 10.1182/blood-2010-12-326298. Epub 2011 Jun 1.

  PMID: 21633086 BACKGROUND

• Gueguen A, Mahevas M, Nzouakou R, Hosseini H, Habibi A, Bachir D, Brugiere P, Lionnet F, Ribei JA, Godeau B, Girot R, Ibrahima V, Calvet D, Galacteros F, Bartolucci P. Sickle-cell disease stroke throughout life: a retrospective study in an adult referral center. Am J Hematol. 2014 Mar;89(3):267-72. doi: 10.1002/ajh.23625.

  PMID: 24779035 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pablo BARTOLUCCI

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 3, 2019
• Study Start: January 5, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7); MA (1)