Blood Loss
Conditions
Keywords
tranexamic acid, blood loss, topical administration, intravenous administration
Brief summary
Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。
Detailed description
Objectives:To assess the efficacy and safety between the two different applying routes. Patients in this project are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral THA(total hip arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while the events of Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction 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 is clamped and closed completely for 2 hours; then the clamp is fully opened.
Interventions
DRUG0.9% sodium chloride
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
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 hip arthroplasty Patients for Ruijin hospital, Shanghai, China
Exclusion criteria
1. Patients who refuse to sign the Inform Consent 2. Had an allergy to TXA. 3. long-term bed \>=3 weeks. 4. Using anticoagulant drugs within a week. 5. Coagulopathy (preoperative platelet count \<150,000/mm3, INR\>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time (\>1.4 times longer than normal) 6. Pregnancy 7. Breastfeeding 8. 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: . 10. Been participating or been participated within a year in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Blood Loss（TBL） | estimated by an equation at the fifth postoperative day | Total Blood Loss（TBL） was estimated 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 |
| Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism) | twelve weeks after surgery | Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) |
| other thromboembolic event | twelve weeks after surgery | Clinically proven Acute Myocardial Infarction 、 acute kidney infarction or cerebral infarction |
| drainage output | ti will be recorded at the first day and the second day after surgery | The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| length of incision leakage | at the every day until the leakage stop,an expected average of 5 days | patients will not be allowed to leave the hospital until the leakage stoped |
| Disseminated Intravascular Coagulation（DIC） | at any day before surgery and the first the fifth day after surgery | include Activated Partial Thromboplastin Time（APTT）；Thrombin Time(TT) Prothrombin Time（PT);International Normalized Ratio(INR);Fibrinogen(FG); Fibrin degradation products(FDPs) D-Dimer |
| ecchymosis area | at the seventh day after surgery | the investigators use the percentage of body surface area to record this outcome |
| human serum albumin | from the day of surgery to the day of discharge,an expected average of 7 days | the investigators record the dosage of the human blood albumin used in each group. |
| American Society of Anesthesiologists Physical Status Classification (ASA class) | at the day of surgery | the investigators record ASA class of every patients in each group. |
Countries
China
Outcome results
None listed