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

Madrid Health Service

Status and phase: Completed; Phase 3

Conditions: Blood Loss

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01881568

TRANEX1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Comparator

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid

Drug: Tranexamic Acid