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    Poster Networking

    Venous Thromboembolism

    Poster Networking Session

    PB0480 - Tinzaparin safety in patients with severe renal impairment

    Sunday, June 25, 2023
    18:30 – 19:30 ET
    Room: Exhibition

      Presenting Author(s)

    • Isabelle Gouin-Thibault, Sr., PhD

      Head of hemostasis department
      Department of Hematology/Hemostasis, Pontchaillou University Hospital of Rennes, Univ Rennes, Irset - Inserm UMR_S 1085, Rennes, France.
      Rennes, Bretagne, France

      • Co-Author(s)

    • Alexandre Mansour, MD

      MD, PhD
      Department of Anesthesia and Critical Care, Pontchaillou University Hospital of Rennes, Univ Rennes, IRSET - Inserm UMR_S 1085, Rennes, France
      Rennes, Bretagne, France

    • CC

      Charlene Caribotti

      PharmD
      Department of Pharmacy, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • AB

      Alice Ballerie

      MD
      Department of Internal Medecine, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • LM

      Laure Maucorps

      MD
      Department of Hematology/Hemostasis, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • PG

      Pierre Gueret

      MD, PhD
      Department of Hematology/Hemostasis, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • FN

      Fabienne Nedelec-Gac

      PharmD
      Department of Hematology/Hemostasis, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • Adeline PONTIS, MD

      Department of Hematology/Hemostasis, Pontchaillou University Hospital of Rennes, Rennes, France ; Univ Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut De Recherche En Santé, Environnement Et Travail) - UMR_S 1085, Rennes, France
      RENNES, Bretagne, France

    • GM

      Guillaume Mahe

      MD, PhD
      Department of Vascular Medecine, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • VS

      Vannier Stephane

      MD
      Department of Neurology, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • NB

      Nathalie Behar

      MD
      Department of Cardiology, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • IC

      Isabelle Cardiet

      PharmD
      Department of Pharmacy, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    • XD

      Xavier Delavenne

      PharmD, PhD
      Department of Pharmacology, Saint-Etienne University Hospital, INSERM, UMR_S1059, University of Lyon, Saint-Etienne, France
      Saint-Etienne, Centre, France

    • TF

      Thierry Frouget

      MD
      Department of Hematology, Pontchaillou University Hospital of Rennes, Rennes, France
      Rennes, Bretagne, France

    Background: Tinzaparin is less dependent on renal excretion than other LMWHs. However, clinical and pharmacological data are still lacking in patients with severe renal insufficiency.

    Aims: We aimed to evaluate, in hospitalized patients with severe renal impairment receiving tinzaparin prophylactic or therapeutic doses: (1) anti-Xa values; (2) bleeding and (3) thrombotic complications.

    Methods: We performed a retrospective observational single-center study, including all in-patients receiving tinzaparin at prophylactic (4500 IU.day-1) or therapeutic (175 IU.kg-1.day-1) dosage and suffering from severe renal insufficiency, defined as a CKD-EPI estimated glomerular filtration rate (eGFR) < 30 mL.min-1, throughout the treatment period.
    Patient characteristics, data related to tinzaparin treatment and outcomes during the treatment period, were recorded. Anti-Xa levels were measured using Liquid anti-Xa® on a STAR Max3 (Stago), with specific calibration. When more than one anti-Xa value was measured during the treatment period, only the highest one was analysed. Severe bleeding was defined according to ISTH criteria. Thrombotic complications comprised venous or arterial ischemic events.

    Results: Between January 2020 and October 2021, 802 tinzaparin treatment periods involving 623 patients were analysed (Table, Figure). Indications were: medical (84%)/peri-operative (16%) prophylactic treatment and VTE (35%), atrial fibrillation (59%) or other (6%) therapeutic treatment. Peak anti-Xa levels (4-6 h after injection), when available, were comparable to those in patients without renal impairment, with no values above 2.0 IU/mL. Major bleedings occurred in 13 (2.4%) and 11 (4.3%) patients receiving prophylactic and therapeutic doses, respectively: mainly gastro-intestinal bleedings in medical setting (prophylactic). Patients with major bleedings had a lower eGFR. There was no association between bleedings and anti-Xa values. No patients had thrombotic complication.

    Conclusion(s): Tinzaparin used at prophylactic and therapeutic standard doses seems to be safe in patients with eGFR < 30mL/min, who are at increased risk for bleeding and thrombosis. A tinzaparin population pharmacokinetics approach, using all anti-Xa measured in these patients, is ongoing.