Total Blood Loss
Conditions
Keywords
tranexamic acid, blood loss, topical administration, intravenous administration
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.
Interventions
DRUGnormal 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.
DRUGTranexamic 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.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary | twelve weeks after surgery | Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism |
| Disseminated Intravascular Coagulation（DIC） | at any day before surgery and the first the fifth day after surgery | — |
| American Society of Anesthesiologists Physical Status Classification (ASA class) | at the day of surgery | — |
| other thromboembolic event | twelve weeks after surgery | Clinically proven Acute Myocardial Infarction、acute kidney infarction or cerebral infarction |
Countries
China
Outcome results
None listed