Pacientes que precisan de una artroplastia de rodilla. Patients with are needed of an arthroplasty of the knee.
Conditions
Interventions
Trade Name: AMCHAFIBRIN 500 mg inyectable
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: TRANEXAMICO ACIDO
CAS Number: 1197-18-8
Other descriptive name: TRANEXAMIC ACID
Concentration u
Sponsors
Fundació Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients older than 18 years Intervention of primary total knee arthroplasty Patient consent to participate in the study 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: Hypersensibility to the study drugs or the bovine proteins (aprotinin) History of thromboembolic disease: ? Cerebrovascular accident ? Ischaemic cardiopathy ? Deep thrombosis venous and/or superficial ? Lung thromboembolism ? Periferical arterial vasculopathy Patients with thromboembolic arrhythmias (AcxFA) Patients with cardiovascular prosthesis Coagulations prothrombotic disease Treatment with with anticonceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 3 intervention compared with habitual haemostasis to diminish at least a 20% of the post-operative bleeding: 1) Tranexamic acid 2) Tissucol 3) Cola de fibrina BSTC;Secondary Objective: ? To assess the efficacy of 3 intervention compared with habitual haemostasis to diminish the blood transfusion. ? To compare between the groups: 1. Haemoglobin pre y postoperative 2. Number of blood transfusion 3. Units of blood transfusion 4. Infections of wound surgery 5. Pain of surgery wound 6. Length of hospital stay 7. Cost-efficacy study;Primary end point(s): To assess if the fibrin glue or the tranexamic acid diminish at least a 20% the blood losses with respect to the habitual haemostasia | — |
Countries
Spain
Outcome results
None listed