Clinical trial NCT02393300: Comparison of Topical Versus Intravenous Tranexamic Acid in TKA
Official title: Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Blood Loss
Keywords: tranexamic acid
blood loss
topical administration
intravenous administration
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.

Detailed description: Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.

Eligibility criteria: Inclusion Criteria:

1. Consented to join in our project.
2. Adult patients (greater than 18 years old)
3. Patients scheduled for primary unilateral knee arthroplasty

Exclusion Criteria:

1. Patients who refuse to sign the Inform Consent
2. Had an allergy to TXA.
3. Using anticoagulant drugs within a week.
4. Coagulopathy (preoperative platelet count \<150,000/mm3,International Sensitivity Index（INR）\>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time \>1.4 times longer than normal.
5. Breastfeeding
6. Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate\<60); or hepatic disfunction(glutamic-pyruvic transaminase\>80 or glutamic oxalacetic transaminase\>80).Retinopathy (disturbances of color vision).

9.History of thromboembolic disease

Primary outcomes:
measure: Total Blood Loss（TBL）
timeFrame: calculated by an equation at the fifth postoperative day
Secondary outcomes:
measure: Transfusion rates
timeFrame: from the day of surgery to the day of discharge,an expected average of 7 days
Other outcomes:
measure: Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary
timeFrame: twelve weeks after surgery
measure: other thromboembolic event
timeFrame: twelve weeks after surgery
measure: drainage output
timeFrame: it will be recorded at the first day and the second day after surgery
measure: human serum albumin usage
timeFrame: from the day of surgery to the day of discharge,an expected average of 7 days
measure: American Society of Anesthesiologists Physical Status Classification (ASA class)
timeFrame: at the day of surgery
measure: Disseminated Intravascular Coagulation（DIC）
timeFrame: at any day before surgery and the first the fifth day after surgery
Locations:
city: Shanghai
country: China
facility: Orthopedic Department of Ruijin hospital
state: Shanghai
Study officials:
affiliation: ruijin hospital，shanghai
name: jianmin feng, master
role: PRINCIPAL_INVESTIGATOR
References: