Clinical trial NCT01881568: Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss
Keywords: Total Knee Arthroplasty, TKA, blood loss
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood transfusion rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Visible blood loss
timeFrame: 24 hours after surgery
measure: Invisible blood loss
timeFrame: 48 hours after surgery
measure: Surgery infection rate
timeFrame: One month after surgery
measure: Range of motion
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Prevalence of drug-related adverse events
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Rate of PE
timeFrame: One month after surgery
measure: Rate of DVT
timeFrame: One month after surgery
measure: Rate or Thrombophlebitis
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Enrique Gomez Barrena, PI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.