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

Blood Loss Clinical Trial

— TRANEX1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881568
• Other study ID #: TRANEX1
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2013
• Last updated: December 2, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
• Tranexamic Acid
Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visible blood loss	Number of milliliters drained in Redon after 24 hours post OP	24 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of PE	Percent of PE during the hospital stay; Percent of PE one month after surgery(safety reasons)	One month after surgery
Secondary	Rate of DVT	Percent of DVT during the hospital stay; Percent of DVT one month after surgery(safety reasons)	One month after surgery
Secondary	Rate or Thrombophlebitis	Percent of Thrombophlebitis during the hospital stay; Percent of Thrombophlebitis one month after surgery(safety reasons)	One month after surgery