Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.
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).


Options:
A: Inclusion Criteria:

* patient scheduled for TKR
* written informed consent
* diagnosis of osteoarthritis

Exclusion Criteria:

* previous intervention on the same Knee (except for meniscectomy)
* Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman
* Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery
B: 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
C: Inclusion Criteria:

* All patients at the participating sites on the waiting list for a unilateral total knee joint replacement

Exclusion Criteria:

* Patients with a history or risk of thrombosis
* Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis
* Subarachnoid haemorrhage
* Hypersensitivity to tranexamic acid or any of its ingredients.
* Refusal of blood products
* Colour blindness
* Complex hematologic disorders requiring manipulation
* Coagulopathy
* Pregnant and Lactating Women
* Anti-coagulant therapy pre-operatively within 5 days of surgery (warfarin, dabigatran, heparin)
* Severe renal failure (eGFR \<29)
D: Inclusion Criteria:

History of ischemic heart disease, stroke, or VTE high risk group, such as obesity, varicose vein of the leg, previous history of PE or DVT, hypercoagulability, recent or ongoing treatment for cancer.

After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk Advanced knee osteoarthritis, Failure of medical treatment or rehabilitation. Hemoglobin \> 11g/dl, No use of non-steroid anti-inflammatory agent one week before operation

Exclusion Criteria:

Preoperative Hemoglobin ≦11 g/dl History of infection or intraarticular fracture of the affective knee Renal function deficiency (GFR \< 30 ml/min/1.73m2) Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy

Answer: B