Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty
- Conditions
- Knee Arthropathy
- Interventions
- Registration Number
- NCT01306370
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
Objectives:
a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee.
Secondaries: To assess the treatment safety. To perform a cost- analyses.
Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia.
Nº of participant centres: 1. Random allocation will be centralised.
Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system.
Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.
Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals.
Statistical analysis: The investigators will perform a comparison of outcomes through the "t" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
- Total knee arthroplasty
- The patient consent to participate
- Intolerance drugs to the study or to bovine protein (aprotinin)
- Antecedent of thromboembolic disease
- Patient with cardiac alterations of the rhythm
- Patients with valvular cardiac prosthesis
- Patients with pro-thrombotic alterations of coagulation
- Treatment with anticonceptive drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fibrin glue BSTC Fibrin glue It is homologous fibrin glue from a single blood donor. Tissucol Fibrin glue It is fibrin glue commercialized from multiple donors. Habitual haemostasis Habitual haemostasis Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis) Tranexamic acid Tranexamic Acid Tranexamic acid is a synthetic derivative of the amino acid lysine. It inhibits fibrinolysis by blocking the lysine binding sites on plasminogen and facilitates the coagulation process.
- Primary Outcome Measures
Name Time Method Postoperative blood loss (mL) During the first 48h after the surgical intervention Blood loss (mL) by the surgical wound collected by drain systems.
- Secondary Outcome Measures
Name Time Method Percentage of patients that need a postoperative blood transfusion During the first postoperative week Percentage of patients with surgical wound infection During the first postoperative month Percentage of patients with surgical wound dehiscence During the first postoperative month Percentage of patients with re-intervention by wound complications During the first postoperative month Incidence of deep venous thrombosis During the first postoperative week Pain of surgical wound During the first postoperative week Units of blood transfusion During the first postoperative week hospital length stay Days Mortality During the first postoperative month
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Catalunya, Spain