Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02393300

Collaborator

(none)

174

Enrollment

Location

Arms

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Blood Loss	Drug: normal saline Drug: Tranexamic Acid Drug: Tranexamic Acid	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group1 60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.	Drug: normal saline The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. Other Names: 0.9% sodium chloride
Experimental: Group2 two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' before the tourniquet deflation and the second dose at 180' after the first dosage	Drug: Tranexamic Acid The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet. Other Names: Cyclokapron
Experimental: Group 3 3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.	Drug: Tranexamic Acid The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. Other Names: Cyclokapron

Arm

Intervention/Treatment

Placebo Comparator: Group1

60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.

Drug: normal saline

The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.

Other Names:

0.9% sodium chloride

Experimental: Group2

two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' before the tourniquet deflation and the second dose at 180' after the first dosage

Drug: Tranexamic Acid

The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet.

Other Names:

Cyclokapron

Experimental: Group 3

3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.

Drug: Tranexamic Acid

The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.

Other Names:

Cyclokapron

Outcome Measures

Primary Outcome Measures

Total Blood Loss（TBL） [calculated by an equation at the fifth postoperative day]
Total Blood Loss（TBL） was calculated with equations described by Gross et al.

Secondary Outcome Measures

Transfusion rates [from the day of surgery to the day of discharge,an expected average of 7 days]
Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay

Other Outcome Measures

Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary [twelve weeks after surgery]
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism
other thromboembolic event [twelve weeks after surgery]
Clinically proven Acute Myocardial Infarction、acute kidney infarction or cerebral infarction
drainage output [it will be recorded at the first day and the second day after surgery]
human serum albumin usage [from the day of surgery to the day of discharge,an expected average of 7 days]
the investigators will record the dosage of the human blood albumin used in each patient.
American Society of Anesthesiologists Physical Status Classification (ASA class) [at the day of surgery]
Disseminated Intravascular Coagulation（DIC） [at any day before surgery and the first the fifth day after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patients who refuse to sign the Inform Consent
Had an allergy to TXA.
Using anticoagulant drugs within a week.
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.
Breastfeeding
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).