Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

Blood Loss Clinical Trial

Official title:

Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312440
• Other study ID #: JTU-GK-010
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2014
• Last updated: November 28, 2015
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2015
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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 。

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Drug:
• 0.9% 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.
• tranexamic 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.
• tranexamic 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 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.

Locations

Country	Name	City	State
China	Orthopedic Department of Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Disseminated Intravascular Coagulation(DIC)	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	No
Other	ecchymosis area	the investigators use the percentage of body surface area to record this outcome	at the seventh day after surgery	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)	Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE)	twelve weeks after surgery	Yes
Secondary	other thromboembolic event	Clinically proven Acute Myocardial Infarction ? acute kidney infarction or cerebral infarction	twelve weeks after surgery	Yes
Secondary	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	No