Total knee arthroplasty bleeding
Conditions
Interventions
Trade Name: Amchafibrin 500mg solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ACIDO TRANEXAMICO
CAS Number: 1197-18-8
Current Sponsor code: ACIDO TRANEXAMICO
Other
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adult patients of both genre aged between 18 and 85 years. - Patients scheduled for primary and unilateral total knee arthroplasty with tourniquet. - Patients who signed informed consent indicating that they have been informed of all pertinent aspects of the trial. 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: -Pregnancy or risk of pregnancy ( fertile women who do not take contraceptives) or lactating. - Participation in a clinical drug research before 3 months in pre-drug administration. - Congenital or acquired bleeding disorder including thrombophilia. - Absolute or relative contraindications of tranexamic acid administration : - venous or arterial thrombosis - pulmonary thromboembolism - paroxysmal atrial fibrillation - chronic kidney failure with GFR <40mm - epilepsy (seizures in the last year)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that tranexamic acid administered 30 minutes before ischemia further reduces free volume of postoperative bleeding in knee replacement (TKR) that administered before the surgical incision.;Secondary Objective: a) To assess whether a second additional dose of 10 mg / kg of tranexamic acid helps to reduce the total postoperative bleeding. b) To assess the incidence of clinically significant thromboembolic events.;Primary end point(s): Perioperative bleeding in milliliters ( ml ) . -Visible Losses : Total amount of bleeding in the draw ( until his retirement ) -Total estimated blood loss : according to formula described in the protocol.;Timepoint(s) of evaluation of this end point: Bleeding from surgery day untill 4th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Adverse events related to treatment with antifibrinolytic : venous thrombosis, pulmonary embolism, arterial thrombosis, acute myocardial infarction , transient ischemic attack , cerebral vascular accident etc. -Units of packed red blood cells transfused and patients transfused -Total tranexamic acid (TXM) dose received;Timepoint(s) of evaluation of this end point: From first acid tranexamic dose untill +/-30 th day post surgery. | — |
Countries
Spain
Contacts
Public ContactServicio de Anestesiología
Servicio de Anestesiología y Reanimación
Outcome results
None listed