Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA (TRANEX1)

Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.

The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Tranexamic Acid

Detailed Description

The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (greater than 18 years old)
• Patients scheduled for primary unilateral knee arthroplasty
• Patients for La Paz- Cantoblanco Hospital, Madrid, Spain

Exclusion Criteria:

• Patients that refuse to sign the Inform Consent
• Allergy to tranexamic acid
• Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine>2mg/dL if mens and >1.8mg/dL if woman); or hepatic disfunction.
• Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged PPT(>1.4 x normal)
• History of thromboembolic disease: CVA, DVT, PE
• Blood dyscrasias
• Retinopathy (disturbances of color vision)
• Jehovah's witnesses
• Pregnancy
• Breastfeeding
• Been participating or been participated a year ago in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow:50mL by irrigation before wound closure50mL by intraarticular administration (Drenofast) after wound closure.; Intravenous administration of Normal saline (0.9% sodium chloride) as follow:100mL before tourniquet realised100mL 3 hours after surgery	Drug: Tranexamic Acid; Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride); Other Names: AMCHAFIBRIN; Drug: Tranexamic Acid; Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each); Other Names: AMCHAFIBRIN,
ACTIVE_COMPARATOR: Comparator; Topical administration of Normal saline (0.9% sodium chloride) as follow:50mL by irrigation before wound closure50mL by intraarticular administration (Drenofast) after wound closure; Intravenous administration of two dosis of Tranexamic Acid as follow:15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), before tourniquet realised15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 3 hours after surgery	Drug: Tranexamic Acid; Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride); Other Names: AMCHAFIBRIN; Drug: Tranexamic Acid; Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each); Other Names: AMCHAFIBRIN,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood transfusion rate	Number of transfused patients in each arm/Total number of patients in each arm	participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visible blood loss	Number of milliliters drained in Redon after 24 hours post OP	24 hours after surgery
Invisible blood loss	Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75*weight(Kg)*[(Hb0-Hb1)/Hb0]+ blood transfused(mL)	48 hours after surgery
Surgery infection rate	Percent of patients with proved signs of infection during the hospital stay; Percent of patients with proved signs of infection one month after surgery(safety reasons)	One month after surgery
Range of motion	- Range (in degrees) from full extension to full flexion during the hospital stay	participants will be followed for the duration of hospital stay, an expected average of 5 days
Prevalence of drug-related adverse events	Rate and characteristics of the adverse events during the hospital stay	participants will be followed for the duration of hospital stay, an expected average of 5 days
Rate of PE	Percent of PE during the hospital stay; Percent of PE one month after surgery(safety reasons)	One month after surgery
Rate of DVT	Percent of DVT during the hospital stay; Percent of DVT one month after surgery(safety reasons)	One month after surgery
Rate or Thrombophlebitis	Percent of Thrombophlebitis during the hospital stay; Percent of Thrombophlebitis one month after surgery(safety reasons)	One month after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Investigators: Principal Investigator: Enrique Gomez Barrena, PI, Hospital Universitario La Paz

Publications and helpful links

General Publications

• Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (ESTIMATE): June 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty, TKA, blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TRANEX1