Hip arthitis MedDRA version: 9.1 Level: LLT Classification code 10031173 Term: Osteoarthropathy
Conditions
Interventions
Trade Name: QUIXIL*SOL NEBUL 2F 5ML
Pharmaceutical Form: Sealant
INN or Proposed INN: PROTEINA COAGULABILE UMANA/TROMBINA UMANA/CALCIO CLORURO
Other descriptive name: Quixil
Concentration unit: ml mi
Sponsors
POLICLINICO SAN DONATO IRCSS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged between 40 and 70 years old, Patients with a diagnosis of symptomatic coxarthrosis requiring a standard hip replacement, Candidate for a uncemented total hip replacement throught a lateral approach (Bauer) Haemostasis carried out through uni-polar electrocoagulation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Anticoagulation, or antiaggregant therapy of any nature that has not been suspended at least 7 days before surgical intervention; Serious deformity, that could excessively extend the intervention (grade III-IV Crowe Etc.); Positive anamnesis for haemoderivatives anaphylaxis; Positive anamnesis for platelet, coagulative or marrow disorders; Alteration of blood tests (PT, PTT, INR) for coagulation; Positive anamnesis for previous exposition to fibrin sealant in the six months preceding the intervention; Previous surgical intervention of any kind on the hip to be replaced; Preoperative treatment with erythropoietin; Patients suffering a serious intraoperative complication; Patients that are candidates to the haemodilution; Patients undergoing postoperative blood recovery with autotrasfusion inside 4 four from surgery; Patients with known intolerance to blood products; Patients with autoimmune immunodeficiency diseases (including known HIV). Patients with other emorragic events not related to the procedure. Female patients who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Besides the social aspect (higher availability in blood banks), this saving also has to be considered from the economic point of view.;Primary end point(s): Quantity of transfused blood during intervention and in the following 7 days, measured in millilitres of blood;Main Objective: This study aims to verify if routine clinical use of Quixil is advantageous in terms of a reduction in the requirement for postoperative blood. | — |
Countries
Italy
Outcome results
None listed