Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

NCT06571552 | Recruiting

• 1 other identifier: NIMAO/2023-2/OM01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors. It is recognized that haemostasis disorders caused by therapeutic apheresis must be corrected in cases of active bleeding. However the methods of correcting these disorders are debatable. Finally, it is unclear when changes in haemostasis associated with coagulation factor deficiency should be corrected. Haemostasis is probably not based solely on the level of blood fibrinogen, but it is most often its threshold that is used to trigger replacement therapy to prevent a supposed risk of haemorrhage. No studies are available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, according to session type and fibrinogen level at the end of the session. The hypothesis of this research is that the link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and propose preventive measures.

Conditions

Hyperfibrinogenemia; Hemostatic Disorder

Keywords

Double Filtration Plasmapheresis; Single Plasma Exchange

Outcome Measures

Primary Outcomes (36)

• Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Day 0, before the session

• Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Day 0, before the session

• Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Day 0, end of session

• Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Day 0, end of session

• Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Day 0, 1 hour after the session

• Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Day 0, 1 hour after the session

• Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Day 0, 4 hours after the session

• Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Day 0, 4 hours after the session

• Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Day 1

• Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Day 1

• Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Day 3

• Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Day 3

• Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Month 1, Day 1, 1 hour after the session

• Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Month 1, Day 1, 1 hour after the session

• Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Month 1, Day 4, 4 hours after the session

• Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Month 1, Day 4, 4 hours after the session

• Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

  Clauss functional method, g/L

  Month 1, Day 3

• Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

  Automated thrombin generation test on Génésia®.

  Month 1, Day 3

• Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Day 0, before the session

• Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Day 0, before the session

• Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Day 0, end of session

• Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Day 0, end of session

• Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Day 0, 1 hour after the session

• Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Day 0, 1 hour after the session

• Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Day 0, 4 hours after the session

• Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Day 0, 4 hours after the session

• Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Day 1

• Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Day 1

• Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Day 3

• Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Day 3

• Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Month 1, Day 1, 1 hour after the session

• Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Month 1, Day 1, 1 hour after the session

• Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Month 1, Day 1, 4 hours after the session

• Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Month 1, Day 1, 4 hours after the session

• Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

  Clauss functional method, g/L

  Month 1, Day 3

• Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

  Automated thrombin generation test on Génésia®.

  Month 1, Day 3

Secondary Outcomes (226)

• Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells

  Day 0, Hour 0

• Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

  Day 0, Hour 1

• Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

  Day 0, Hour 4

• Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

  Day 1

• Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

  Day 3

Other Outcomes (6)

• Gender of patients

  Day 0, Hour 0

• Age of patients

  Day 0, Hour 0

• Weight of patients

  Day 0, Hour 0

Study Arms (2)

Patients benefitting from Single Plasma Exchange followed by Double Filtration Plasmapheresis

ACTIVE COMPARATOR

For the patients in this group, the first cycle (T1) will consist of Single Plasma Exchange and the second cycle (T2) of Double Filtration Plasmapheresis.

Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis

Patients benefitting from Double Filtration Plasmapheresis followed by Single Plasma Exchange

ACTIVE COMPARATOR

For the patients in this group, the first cycle (T1) will consist of Double Filtration Plasmapheresis and the second cycle (T2) of Single Plasma Exchange.

Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis

Interventions

Single Plasma Exchange followed by Double Filtration Plasmapheresis PROCEDURE

Double Filtration Plasmapheresis followed by Single Plasma Exchange

Patients benefitting from Double Filtration Plasmapheresis followed by Single Plasma Exchange; Patients benefitting from Single Plasma Exchange followed by Double Filtration Plasmapheresis

Eligibility Criteria

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

You may qualify if:

• Patients without renal failure treated with chronic therapeutic plasmapheresis with a minimum treatment interval of 10 days and who can be treated with single plasma exchange (SPE) or double filtration plasmapheresis (DFPP) in accordance with the international recommendations.
• Therapeutic plasmapheresis with regional citrate anticoagulation.
• Patients over 18 years of age.
• Patient affiliated to or benefiting from a social security scheme.

You may not qualify if:

• Patients treated with oral anticoagulants or anti-platelet agents.
• Patients treated for hypercholesterolaemia or hypertriglyceridaemia; hyperviscosity, acquired haemophilia or nephrotic syndrome.
• Indication for substitution with fresh frozen plasma (FFP) for the treatment of the disease.
• Patient under court protection, guardianship or curatorship.
• Patient unable to give consent.
• Patient for whom it is impossible to give informed information.
• Pregnant or breast-feeding patients.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Emilie PAMBRUN, Docteur

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Sylvie BOUVIER, Docteur

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Jean-Christophe GRIS, Professor

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Mathieu FORTIER

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier MORANNE, Professor

CONTACT

+334.66.68.31.49; olivier.moranne@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients being monitored for chronic therapeutic plasmapheresis with regional citrate anticoagulation will be recruited from the Nephrology Department at Nîmes University Hospital. After receiving written informed consent (inclusion visit), patients will be randomized to determine the nature of their first cycle (single plasma exchange or double filtration plasmapheresis. The next cycle will vary accordingly: DFPP if the first cycle was single plasma exchange, and single plasma exchange if the first session was DFPP.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: December 17, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

FR (1)