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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-09-30

Brief Summary

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Dose of anticoagulant prophylaxis in patients with continuous veno-venous hemodiafiltration may be insufficient to keep anti-Xa factor activity in prophylactic range.

Detailed Description

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Coagulation disorders are one of the most common complications in critically ill patients. Among them deep vein thrombosis and pulmonary embolism are the most significant factors increasing morbidity and mortality in ICU patients. Use of anticoagulant prophylaxis aims to prevent these dangerous complications. Most commonly used anticoagulant prophylaxis agents are low molecular weight heparins (LMWH). LMWH therapeutic efficiency is measured with activity of anti-Xa factor, that should range between 0.2 and 0.4 IU/mL in order to prevent thrombotic complications. Due to grave general condition, critically ill patients may often develop acute kidney injury (AKI), that requires renal replacement therapy (RRT). Because of haemodynamic instability the safest therapeutic choice seems to be continuous veno-venous hemodiafiltration (CVVHDF). This RRT mode removes particles in the size of few daltons even up to 10 kilodaltons (kDa) such as metabolic product waste, ions, hormones etc. LMWH with average molecular weight of 4.5 kDa and fondaparinux with average molecular weight of 1.7 kDa may be removed during CVVHDF resulting in insufficient activity of anti-Xa factor thus increasing the risk of thrombotic complications in critically ill patients.

Conditions

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Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis

Keywords

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continuous veno-venous hemodiafiltration enoxaparin low molecular weight heparin LMWH CVVHDF anticoagulant prophylaxis critically ill fondaparinux anti-Xa activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All adult Intensive Care Unit patients between 18 and 80 years old requiring treatment with CVVHDF;
* 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

* Indications for low molecular weight heparin use other than anticoagulant prophylaxis;
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

Central Contacts

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Aleksander Aszkielowicz, M.D.

Role: CONTACT

Phone: 509465855

Email: [email protected]

Radoslaw Owczuk, Prof.

Role: CONTACT

Phone: 605408140

Email: [email protected]

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.

Reference Type DERIVED
PMID: 40413237 (View on PubMed)

Other Identifiers

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M000000346978

Identifier Type: -

Identifier Source: org_study_id