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Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.

Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04671160
Enrollment
80
Registered
2020-12-17
Start date
2021-01-04
Completion date
2022-09-30
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTAssessment 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.

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Medical University of Gdansk
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anti-Xa assay9 hoursAnti-Xa assay as a tool to measure anticoagulation activity in subjects just before administration of anticoagulant prophylaxis, 3 hours, 6 hours and 9 hours after administration of prophylactic dose of enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily.

Countries

Poland

Contacts

Primary ContactAleksander Aszkielowicz, M.D.
aszkielowicz@gumed.edu.pl509465855
Backup ContactRadoslaw Owczuk, Prof.
r.owczuk@gumed.edu.pl605408140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026