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

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ClinicalTrials.gov Identifier: NCT01881568
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Enrique Gómez Barrena, Hospital Universitario La Paz

Tracking Information
First Submitted Date  ICMJE February 5, 2013
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
Blood transfusion rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
Number of transfused patients in each arm/Total number of patients in each arm
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01881568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
  • Visible blood loss [ Time Frame: 24 hours after surgery ]
    Number of milliliters drained in Redon after 24 hours post OP
  • Invisible blood loss [ Time Frame: 48 hours after surgery ]
    Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75*weight(Kg)*[(Hb0-Hb1)/Hb0]+ blood transfused(mL)
  • Surgery infection rate [ Time Frame: One month after surgery ]
    • 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)
  • Range of motion [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    - Range (in degrees) from full extension to full flexion during the hospital stay
  • Prevalence of drug-related adverse events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Rate and characteristics of the adverse events during the hospital stay
  • Rate of PE [ Time Frame: One month after surgery ]
    • Percent of PE during the hospital stay
    • Percent of PE one month after surgery(safety reasons)
  • Rate of DVT [ Time Frame: One month after surgery ]
    • Percent of DVT during the hospital stay
    • Percent of DVT one month after surgery(safety reasons)
  • Rate or Thrombophlebitis [ Time Frame: One month after surgery ]
    • Percent of Thrombophlebitis during the hospital stay
    • Percent of Thrombophlebitis one month after surgery(safety reasons)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
  • Visible blood loss [ Time Frame: 24 hours after surgery ]
    Number of milliliters drained in Redon after 24 hours post OP
  • Invisible blood loss [ Time Frame: 48 hours after surgery ]
    Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75*weight(Kg)*[(Hb0-Hb1)/Hb0]+ blood transfused(mL)
  • Surgery infection rate [ Time Frame: One month after surgery ]
    • Percent of patients with proved signs of infection during the hospitalary stay
    • Percent of patients with proved signs of infection one month after surgery(safety reasons)
  • Range of motion [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    - Range (in degrees) from full extension to full flexion during the hospitalary stay
  • Prevalence of drug-related adverse events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Rate and characteristics of the adverse events during the hospitalary stay
  • Rate of PE [ Time Frame: One month after surgery ]
    • Percent of PE during the hospitalary stay
    • Percent of PE one month after surgery(safety reasons)
  • Rate of DVT [ Time Frame: One month after surgery ]
    • Percent of DVT during the hospitalary stay
    • Percent of DVT one month after surgery(safety reasons)
  • Rate or Thrombophlebitis [ Time Frame: One month after surgery ]
    • Percent of Thrombophlebitis during the hospitalary stay
    • Percent of Thrombophlebitis one month after surgery(safety reasons)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Blood Loss
Intervention  ICMJE
  • Drug: Tranexamic Acid
    Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
    Other Name: AMCHAFIBRIN
  • Drug: Tranexamic Acid
    Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)
    Other Name: AMCHAFIBRIN,
Study Arms  ICMJE
  • 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
    Intervention: Drug: Tranexamic Acid
  • Active Comparator: 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
    Intervention: Drug: Tranexamic Acid
Publications * Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Pérez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
79
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01881568
Other Study ID Numbers  ICMJE TRANEX1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Enrique Gómez Barrena, Hospital Universitario La Paz
Study Sponsor  ICMJE Hospital Universitario La Paz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Enrique Gomez Barrena, PI Hospital Universitario La Paz
PRS Account Hospital Universitario La Paz
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP