Safety Evaluation of Use Sodic Enoxaparin
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate safety, not inferiority clinical and
      pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when
      compared with Clexane product, produced by Laboratory Sanofi-Aventis in 60 patients with
      Chronic Renal Desease.
    

Detailed description: 
      Hemodialysis is a filtering and cleaning process of endogenous and exogenous metabolic blood
      products. The level control of anticoagulants in patients with chronic renal disease is
      indispensable. Evidence of clotting as TTPa and evidence of activity of anti-factor Xa should
      be used as a substrate to protect these patients, undergoing dialysis. The Enoxaparin sodium
      is one that acts as antithrombin-factor Xa inhibitor of acting directly on the inactivation
      of antithrombin. Thus, small-chain molecules (low molecular weight) as Enoxaparin show
      fundamentally anti-Xa high end and low end antitrombotic. The purpose of this study was to
      evaluate safety, not inferiority clinical and pharmacodynamic profile of the drug Enoxaparin
      Sodium produced by laboratory Blausiegel when compared with Clexane product, produced by
      Laboratory Sanofi-Aventis in 60 patients with Chronic Renal Desease. The study was kind of
      parallel, randomized, double-blind and systematic sampling. The drugs were administered
      during 12 consecutive dialysis sessions at a dose of 1 mg / kg. The activity of the drugs was
      verified by the strength of markers TTPa and anti-Xa and security was seen through adverse
      reactions and the evaluation function of capillaries.

      The study was conducted 60 patients with chronic renal desease to both sexes, above 18 years
      aged, who were carrying out haemodialysis treatment during 3 times a week and satisfied
      inclusion criteria. The investigational products were randomly administered to patients in 12
      consecutive dialysis sessions, at a dose of 1 mg / kg. The primary endpoint was safety of
      using the drug evaluated by monitoring events as:

        -  Loss of blood clotting by the system

        -  Blood coagulation and loss of capillary vein.

        -  Thrombus of capillary in 3 sessions of monitoring.

        -  Increase in the patient's hematocrit

        -  Thrombocytopenia

        -  Hematoma

        -  Fever

        -  Allergic reactions

      The secondary endpoint was evaluation of non inferiority clinic, observed over the criteria
      in maintaining the non-coagulation of the extracorporeal circuit during hemodialysis and the
      pharmacodynamic curve effect of enoxaparin sodium verified by the strength of markers TTPa,
      anti-Xa and anti-IIa.
    

Intervention name(s): Enoxaparin sodic
Intervention type(s): Biological
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: enoxaparin; chronic renal disease; Anticoagulant activity of enoxaparin sodic