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

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04671160
• Other study ID #: M000000346978
• Status: Not yet recruiting
• Start date: January 4, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2020
• Source: Medical University of Gdansk
• Contact: Aleksander Aszkielowicz, M.D.
• Phone: 509465855
• Email: aszkielowicz[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Poland	Medical University of Gdansk - Departament of Anesthesiology and Intensive Care	Gdansk	Pomorskie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Gdansk	Baxter Healthcare Corporation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Xa assay	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.	9 hours