Clinical trial NCT05148377: UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.
Official title: UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis Complication
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.
Primary purpose: TREATMENT

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;

Eligibility criteria: 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.

Primary outcomes:
measure: Blood loss due to system coagulation during 4 weeks of hemodialysis
timeFrame: 4 weeks
measure: Loss of venous capillary by clot formation during 4 weeks of hemodialysis
timeFrame: 4 weeks
measure: Change of the useful volume of the system in the dialyzer (priming of dialyzer)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: