Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA
- Registration Number
- NCT01881568
- Lead Sponsor
- Hospital Universitario La Paz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- Adult patients (greater than 18 years old)
- Patients scheduled for primary unilateral knee arthroplasty
- Patients for La Paz- Cantoblanco Hospital, Madrid, Spain
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Tranexamic Acid 1. Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow: * 50mL by irrigation before wound closure * 50mL by intraarticular administration (Drenofast) after wound closure. 2. Intravenous administration of Normal saline (0.9% sodium chloride) as follow: * 100mL before tourniquet realised * 100mL 3 hours after surgery Comparator Tranexamic Acid 1. Topical administration of Normal saline (0.9% sodium chloride) as follow: * 50mL by irrigation before wound closure * 50mL by intraarticular administration (Drenofast) after wound closure 2. Intravenous administration of two dosis of Tranexamic Acid as follow: * 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), before tourniquet realised * 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 3 hours after surgery
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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)
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)
Trial Locations
- Locations (1)
Hospital Universitario La Paz
🇪🇸Madrid, Spain