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Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nadroparin (intravenous Infusion)
Nadroparin (subcutaneous group)
Sponsored by
Clinique Saint Pierre Ottignies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults patients > 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated

Exclusion Criteria:

  • renal failure determined by glomerular filtration rate (GFR) < 30 ml/min or need for renal replacement therapy
  • liver cirrhosis
  • intravascular disseminated coagulation
  • contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,…)
  • patients receiving low dose of vasopressor (norepinephrine < 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intravenous group

    Subcutaneous group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Peak anti-Xa activity
    Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration

    Secondary Outcome Measures

    Trough anti-Xa activity
    Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
    AUC (0-24h)
    Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin

    Full Information

    First Posted
    July 8, 2021
    Last Updated
    July 19, 2021
    Sponsor
    Clinique Saint Pierre Ottignies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04982055
    Brief Title
    Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients
    Official Title
    Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 8, 2015 (Actual)
    Primary Completion Date
    December 31, 2020 (Actual)
    Study Completion Date
    December 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clinique Saint Pierre Ottignies

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients
    Detailed Description
    The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous group
    Arm Type
    Experimental
    Arm Title
    Subcutaneous group
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Nadroparin (intravenous Infusion)
    Intervention Description
    Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU
    Intervention Type
    Drug
    Intervention Name(s)
    Nadroparin (subcutaneous group)
    Intervention Description
    Subcutaneous route of administration of nadroparin 3800 IU
    Primary Outcome Measure Information:
    Title
    Peak anti-Xa activity
    Description
    Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
    Time Frame
    Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
    Secondary Outcome Measure Information:
    Title
    Trough anti-Xa activity
    Description
    Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
    Time Frame
    Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
    Title
    AUC (0-24h)
    Description
    Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin
    Time Frame
    0-24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults patients > 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated Exclusion Criteria: renal failure determined by glomerular filtration rate (GFR) < 30 ml/min or need for renal replacement therapy liver cirrhosis intravascular disseminated coagulation contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,…) patients receiving low dose of vasopressor (norepinephrine < 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35381407
    Citation
    De Schryver N, Serck N, Eeckhoudt S, Laterre PF, Wittebole X, Gerard L. Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial. J Crit Care. 2022 Aug;70:154029. doi: 10.1016/j.jcrc.2022.154029. Epub 2022 Apr 2.
    Results Reference
    derived

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    Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients

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