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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 。
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Placebo Comparator | 60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away. |
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| Group2 | Experimental | 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' prior to skin incision and the second dose at 180' after the first dosage. |
|
| Group 3 | Experimental | 3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% sodium chloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss（TBL） | Total Blood Loss（TBL） was estimated with equations described by Gross et al. | estimated by an equation at the fifth postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism) |
| Measure | Description | Time Frame |
|---|---|---|
| length of incision leakage | patients will not be allowed to leave the hospital until the leakage stoped | at the every day until the leakage stop,an expected average of 5 days |
| Disseminated Intravascular Coagulation（DIC） |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jianmin feng, master | ruijin hospital，shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Department of Ruijin hospital | Shanghai | Shanghai Municipality | 200001 | China |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| tranexamic acid | Drug | 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 | Drug | 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. 60 Milliliters（ml） by irrigation for 3 minutes before wound closure. |
|
|
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) |
| twelve weeks after surgery |
| other thromboembolic event | Clinically proven Acute Myocardial Infarction 、 acute kidney infarction or cerebral infarction | twelve weeks after surgery |
| drainage output | The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery | ti will be recorded at the first day and the second 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
| at any day before surgery and the first the fifth day after surgery |
| ecchymosis area | the investigators use the percentage of body surface area to record this outcome | at the seventh day after surgery |
| human serum albumin | the investigators record the dosage of the human blood albumin used in each group. | 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) | the investigators record ASA class of every patients in each group. | at the day of surgery |
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |