Status:
UNKNOWN
Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.
Lead Sponsor:
Medical University of Gdansk
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis
Eligibility:
All Genders
18-80 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04671160
Start Date
January 4 2021
End Date
September 30 2022
Last Update
December 17 2020
Active Locations (1)
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1
Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship, Poland, 80-214