Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Total Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393300
• Other study ID #: JTU-GK-011
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2015
• Last updated: April 3, 2018
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Total Blood Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Orthopedic Department of Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary	Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism	twelve weeks after surgery
Other	other thromboembolic event	Clinically proven Acute Myocardial Infarction?acute kidney infarction or cerebral infarction	twelve weeks after surgery
Other	drainage output		it will be recorded at the first day and the second day after surgery
Other	human serum albumin usage	the investigators will record the dosage of the human blood albumin used in each patient.	from the day of surgery to the day of discharge,an expected average of 7 days
Other	American Society of Anesthesiologists Physical Status Classification (ASA class)		at the day of surgery
Other	Disseminated Intravascular Coagulation(DIC)		at any day before surgery and the first the fifth day after surgery
Primary	Total Blood Loss(TBL)	Total Blood Loss(TBL) was calculated with equations described by Gross et al.	calculated by an equation at the fifth postoperative day
Secondary	Transfusion rates	Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay	from the day of surgery to the day of discharge,an expected average of 7 days