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

NCT01881568 | Completed Phase 3 DMC

• 1 other identifier: TRANEX1
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Blood Loss

Keywords

Total Knee Arthroplasty, TKA, blood loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Visible blood loss

  24 hours after surgery

• Invisible blood loss

  48 hours after surgery

• Surgery infection rate

  One month after surgery

• Range of motion

  participants will be followed for the duration of hospital stay, an expected average of 5 days

• Prevalence of drug-related adverse events

  participants will be followed for the duration of hospital stay, an expected average of 5 days

Study Arms (2)

Experimental

EXPERIMENTAL

1. Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow: * 50mL by irrigation before wound closure * 50mL by intraarticular administration (Drenofast) after wound closure. 2. Intravenous administration of Normal saline (0.9% sodium chloride) as follow: * 100mL before tourniquet realised * 100mL 3 hours after surgery

Drug: Tranexamic Acid

Comparator

ACTIVE COMPARATOR

1. Topical administration of Normal saline (0.9% sodium chloride) as follow: * 50mL by irrigation before wound closure * 50mL by intraarticular administration (Drenofast) after wound closure 2. 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 realised * 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 3 hours after surgery

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)

Also known as: AMCHAFIBRIN

Experimental

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 25471907 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Enrique Gomez Barrena, PI

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: June 19, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

ES (1)