Hemodialysis Complication
Conditions
Brief summary
The objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured by by Roche Laboratory in patients with renal failure undergoing hemodialysis treatment
Detailed description
Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparino tested. The study was conducted with the participation of 110 chronic renal failure patients of both sexes. over 18 years old who are undergoing hemodialysis treatment 3 times a week and who fit inclusion and exclusion criteria. The investigational products properly patients were administered during 12 consecutive treatment sessions. Hemodialysis at a dose of 150 IU per kg of weight. The study patients were followed clinically and on a laboratory basis in all hemodialysis sessions according to criteria established by the protocol for verifying the safety in use of the product in study. The evaluation parameters are: * Pharmacodynamic effect curve (activity) of heparin verified by dosing of TYPE and anti-Xa markers. * Effectiveness in maintaining blood coagulation during hemodialysis. * Blood loss by coagulation of the system; * Blood clotting and venous capillary loss; * Trunk of the capillary diolysor in the 12 follow-up sessions. * Safety in drug use through event monitoring complicating the use of heparin as: * Increased hematocrit of the patient; * Thrombocytopenia; * Bruise; * Fever; * Reactions to allergic agents;
Interventions
DRUGLiquaemin
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
DRUGHeptar
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The pharmaceutical presentation of the medication to be studied is: solution for injection packaged in 5ml vial and 0.25ml ampoule. All doses have been prepared prior to administration to patients by the LAL Clinic Pharmacy which knows the randomization of the study. It is preparation consisted of preparing the dose of each patient previously calculated based on the weight of each patient and the pharmaceutical presentation of the product randomized into standard 3 ml syringes.
Intervention model description
Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults of both sexes, regardless of color or social class; * Age over 18 years, with good clinical characteristics at medical discretion; * Research patients who agree to participate in the study and sign the consent form free and informed; * Chronic renal failure patients on dialysis regimen (3 times a week). * Chronic Kidney Failure with indication for anticoagulant during dialysis
Exclusion criteria
* Not agreeing with the terms described in the informed consent; * Research patients with sensitivity to sadistic heparin; * Research patients with hypersensitivity to benzyl alcohol; * Research patients with a history of bleeding or disease that change in coagulation may worsen or terminate the clinical picture, such as ulcer gastric; * Research patients with a history of peptic ulcer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss due to system coagulation during 4 weeks of hemodialysis | 4 weeks | Evaluation of the change of the useful volume of the system below |
| Loss of venous capillary by clot formation during 4 weeks of hemodialysis | 4 weeks | Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions |
| Change of the useful volume of the system in the dialyzer (priming of dialyzer) | 4 weeks | Occurrence of events related to the reduction of the useful volume of the system below 80% by thrombus formation in the dialyzer in the 12 hemodialysis sessions |
Outcome results
None listed