Blood Loss
Conditions
Keywords
Total Knee Arthroplasty, TKA, blood loss
Brief summary
The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).
Detailed description
The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.
Interventions
DRUGTranexamic Acid
Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
Sponsors
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (greater than 18 years old) * Patients scheduled for primary unilateral knee arthroplasty * Patients for La Paz- Cantoblanco Hospital, Madrid, Spain
Exclusion criteria
* Patients that refuse to sign the Inform Consent * Allergy to tranexamic acid * Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine\>2mg/dL if mens and \>1.8mg/dL if woman); or hepatic disfunction. * Coagulopathy (preoperative platelet count \<150,000/mm3, INR\>1.4, prolonged PPT(\>1.4 x normal) * History of thromboembolic disease: CVA, DVT, PE * Blood dyscrasias * Retinopathy (disturbances of color vision) * Jehovah's witnesses * Pregnancy * Breastfeeding * Been participating or been participated a year ago in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion rate | participants will be followed for the duration of hospital stay, an expected average of 5 days | Number of transfused patients in each arm/Total number of patients in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invisible blood loss | 48 hours after surgery | Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75\*weight(Kg)\*\[(Hb0-Hb1)/Hb0\]+ blood transfused(mL) |
| Surgery infection rate | One month after surgery | * Percent of patients with proved signs of infection during the hospital stay * Percent of patients with proved signs of infection one month after surgery(safety reasons) |
| Range of motion | participants will be followed for the duration of hospital stay, an expected average of 5 days | \- Range (in degrees) from full extension to full flexion during the hospital stay |
| Visible blood loss | 24 hours after surgery | Number of milliliters drained in Redon after 24 hours post OP |
| Rate of PE | One month after surgery | * Percent of PE during the hospital stay * Percent of PE one month after surgery(safety reasons) |
| Rate of DVT | One month after surgery | * Percent of DVT during the hospital stay * Percent of DVT one month after surgery(safety reasons) |
| Rate or Thrombophlebitis | One month after surgery | * Percent of Thrombophlebitis during the hospital stay * Percent of Thrombophlebitis one month after surgery(safety reasons) |
| Prevalence of drug-related adverse events | participants will be followed for the duration of hospital stay, an expected average of 5 days | Rate and characteristics of the adverse events during the hospital stay |
Countries
Spain
Outcome results
None listed