Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.
NCT ID: NCT04671160
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2021-01-04
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Group treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis.
Assessment the activity of anti-Xa factor.
Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
2
Group treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
Assessment the activity of anti-Xa factor.
Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
3
Group not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis.
Assessment the activity of anti-Xa factor.
Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
4
Group not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
Assessment the activity of anti-Xa factor.
Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
Interventions
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Assessment the activity of anti-Xa factor.
Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
Eligibility Criteria
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Inclusion Criteria
* Indications for anticoagulant prophylaxis with enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily;
* Treatment with continuous veno-venous hemodiafiltration.
Exclusion Criteria
* Intracranial hemorrhage;
* Incident of serious bleeding within a week before admission to ICU, if not managed;
* Disseminated intravascular coagulopathy;
* Heparin induced thrombocytopenia;
* Hypersensitivity or allergic reaction to enoxaparin or fondaparinux;
* Thrombocytopenia \< 50 G/L;
* Prothrombin time \< 20% or INR (international normalized ratio) \> 1.7;
* Use of antiplatelet drugs;
* Presence of congenital coagulopathy.
18 Years
80 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Medical University of Gdansk
OTHER
Responsible Party
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Locations
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Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Radoslaw Owczuk, Prof.
Role: primary
Aleksander Aszkielowicz, M.D.
Role: backup
References
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Aszkielowicz A, Steckiewicz KP, Owczuk R. Evaluating the impact of continuous venovenous hemodiafiltration on the efficacy of prophylactic fondaparinux doses: a prospective single-center observational study. Sci Rep. 2025 May 24;15(1):18083. doi: 10.1038/s41598-025-03365-1.
Other Identifiers
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M000000346978
Identifier Type: -
Identifier Source: org_study_id