Clinical trial NCT02312440: Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty
Official title: Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss
Keywords: tranexamic acid
blood loss
topical administration
intravenous administration
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Blood Loss（TBL）
timeFrame: estimated by an equation at the fifth postoperative day
Secondary outcomes:
measure: Transfusion rates
timeFrame: from the day of surgery to the day of discharge,an expected average of 7 days
measure: Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)
timeFrame: twelve weeks after surgery
measure: other thromboembolic event
timeFrame: twelve weeks after surgery
measure: drainage output
timeFrame: ti will be recorded at the first day and the second day after surgery
Other outcomes:
measure: length of incision leakage
timeFrame: at the every day until the leakage stop,an expected average of 5 days
measure: Disseminated Intravascular Coagulation（DIC）
timeFrame: at any day before surgery and the first the fifth day after surgery
measure: ecchymosis area
timeFrame: at the seventh day after surgery
measure: human serum albumin
timeFrame: from the day of surgery to the day of discharge,an expected average of 7 days
measure: American Society of Anesthesiologists Physical Status Classification (ASA class)
timeFrame: at the day of surgery
Locations:
city: Shanghai
country: China
facility: Orthopedic Department of Ruijin hospital
state: Shanghai
Study officials:
affiliation: ruijin hospital，shanghai
name: jianmin feng, master
role: PRINCIPAL_INVESTIGATOR
References: