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

Study acronym: APHERCOAG
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Jun 2025 → Dec 17, 2026
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Record History

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  1. Notable Primary completion pushed from Jun 2025 to Dec 17, 2026 Show 4 more changesShow less
    • Study completion pushed from Jun 2026 to Feb 2, 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 40 of 226 entries
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 2025 to Jun 2025
    • Study completion date: Jun 2025 to Jun 2026
    • Start date changed from estimate of Sep 2024 to Dec 17, 2024
    • Secondary endpoints: 220 to 226
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06571552
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions
(from sponsor)
Hyperfibrinogenemia, Hemostatic Disorder
Related terms Hemostatic Disorders
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov