Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

NCT02393300 | Completed Phase 3

• 1 other identifier: JTU-GK-011
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Blood Loss

Keywords

tranexamic acid; blood loss; topical administration; intravenous administration

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss（TBL）

  Total Blood Loss（TBL） was calculated with equations described by Gross et al.

  calculated by an equation at the fifth postoperative day

Secondary Outcomes (1)

• Transfusion rates

  from the day of surgery to the day of discharge,an expected average of 7 days

Other Outcomes (6)

• Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary

  twelve weeks after surgery

• other thromboembolic event

  twelve weeks after surgery

• drainage output

  it will be recorded at the first day and the second day after surgery

Study Arms (3)

Group1

PLACEBO COMPARATOR

60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.

Drug: normal saline

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' before the tourniquet deflation and the second dose at 180' after the first dosage

Drug: Tranexamic Acid

Group 3

EXPERIMENTAL

3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.

Drug: Tranexamic Acid

Interventions

normal saline 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.

Also known as: 0.9% sodium chloride

Group1

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.

Also known as: Cyclokapron

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consented to join in our project.
• Adult patients (greater than 18 years old)
• Patients scheduled for primary unilateral knee arthroplasty

You may not qualify if:

• Patients who refuse to sign the Inform Consent
• Had an allergy to TXA.
• Using anticoagulant drugs within a week.
• 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.
• Breastfeeding
• 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).
• History of thromboembolic disease

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Orthopedic Department of Ruijin hospital

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Exsanguination; Hemorrhage

Interventions

Saline Solution; Sodium Chloride; Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• jianmin feng, master

  ruijin hospital，shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD in Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: March 15, 2015
• First Posted: March 19, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 4, 2018

Record last verified: 2015-11

Locations

CN (1)