Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

NCT02312440 | Completed Phase 3

• 1 other identifier: JTU-GK-010
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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 。

Conditions

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 estimated with equations described by Gross et al.

  estimated by an equation at the fifth postoperative day

Secondary Outcomes (4)

• Transfusion rates

  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)

  twelve weeks after surgery

• other thromboembolic event

  twelve weeks after surgery

• drainage output

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

Other Outcomes (5)

• length of incision leakage

  at the every day until the leakage stop,an expected average of 5 days

• Disseminated Intravascular Coagulation（DIC）

  at any day before surgery and the first the fifth day after surgery

• ecchymosis area

  at the seventh day after surgery

Study Arms (3)

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.

Drug: 0.9% sodium chloride

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.

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 hip cavity for at least 3 minutes before wound closure and then sucked away.

Drug: tranexamic acid

Interventions

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.

Also known as: normal saline

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

Group2

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 hip arthroplasty Patients for Ruijin hospital, Shanghai, China

You may not qualify if:

• Patients who refuse to sign the Inform Consent
• Had an allergy to TXA.
• long-term bed \>=3 weeks.
• Using anticoagulant drugs within a week.
• 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)
• Pregnancy
• 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: .
• Been participating or been participated within a year in another clinical trial

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

Hemorrhage

Interventions

Sodium Chloride; Saline Solution; Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: November 10, 2014
• First Posted: December 9, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-05

Locations

CN (1)