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

• Conditions: Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis
• Interventions: Diagnostic Test: Assessment the activity of anti-Xa factor.

• Registration Number: NCT04671160
• Lead Sponsor: Medical University of Gdansk

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-15
• Last Update Submitted: 2020-12-15
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17
• Study Start: 2021-01-04
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Assessment the activity of anti-Xa factor.	Group treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis.
2	Assessment the activity of anti-Xa factor.	Group treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
3	Assessment the activity of anti-Xa factor.	Group not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis.
4	Assessment the activity of anti-Xa factor.	Group not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.

Primary Outcome Measures

Name	Time	Method
Anti-Xa assay	9 hours	Anti-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.

Trial Locations

Locations (1)

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care; 🇵🇱 Gdańsk, Pomorskie, Poland