Knee Arthropathy
Conditions
Keywords
primary knee arthroplasty, fibrin glue, tranexamic acid, topic
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.
Interventions
DRUGTranexamic Acid
Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule
DRUGFibrin glue
Topical administration, before to close the surgical wound. Dosage: 2 mL.
OTHERHabitual haemostasis
The surgical habitual haemostasis.
Sponsors
Banc de Sang i Teixits
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total knee arthroplasty * The patient consent to participate
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative blood loss (mL) | During the first 48h after the surgical intervention | Blood loss (mL) by the surgical wound collected by drain systems. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of patients that need a postoperative blood transfusion | During the first postoperative week |
| Units of blood transfusion | During the first postoperative week |
| hospital length stay | Days |
| Mortality | During the first postoperative month |
| Pain of surgical wound | During the first postoperative week |
Countries
Spain
Outcome results
None listed