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

Sponsor

Medical University of Gdansk (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04671160

Collaborator

Baxter Healthcare Corporation (Industry)

Enrollment

Location

20.8

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis	Diagnostic Test: Assessment the activity of anti-Xa factor.

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 4, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
1 Group treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis.	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.
2 Group treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.	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.
3 Group not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis.	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.
4 Group not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.	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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.