A Phase 3 interventional study of normal saline and Tranexamic Acid in Total Blood Loss, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Treatment
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 174 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
9.History of thromboembolic disease
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
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
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 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.
Also known as: 0.9% sodium chloride
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.
Also known as: Cyclokapron
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.
Also known as: Cyclokapron
Total Blood Loss（TBL）
Total Blood Loss（TBL） was calculated with equations described by Gross et al.
Time frame: calculated by an equation at the fifth postoperative day
Transfusion rates
Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay
Time frame: from the day of surgery to the day of discharge,an expected average of 7 days
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism
Time frame: twelve weeks after surgery
other thromboembolic event
Clinically proven Acute Myocardial Infarction、acute kidney infarction or cerebral infarction
Time frame: twelve weeks after surgery
drainage output
Time frame: it will be recorded at the first day and the second day after surgery
human serum albumin usage
the investigators will record the dosage of the human blood albumin used in each patient.
Time frame: from the day of surgery to the day of discharge,an expected average of 7 days
American Society of Anesthesiologists Physical Status Classification (ASA class)
Time frame: at the day of surgery
Disseminated Intravascular Coagulation（DIC）
Time frame: at any day before surgery and the first the fifth day after surgery
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine