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Trial record 95 of 419 for:    TRANEXAMIC ACID

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

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).

Condition or disease Intervention/treatment Phase
Blood Loss Drug: Tranexamic Acid Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
Other Name: AMCHAFIBRIN

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
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,




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Visible blood loss [ Time Frame: 24 hours after surgery ]
    Number of milliliters drained in Redon after 24 hours post OP

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881568


Locations
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Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
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Principal Investigator: Enrique Gomez Barrena, PI Hospital Universitario La Paz

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enrique Gómez Barrena, Professor, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01881568     History of Changes
Other Study ID Numbers: TRANEX1
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Enrique Gómez Barrena, Hospital Universitario La Paz:
Total Knee Arthroplasty, TKA, blood loss
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants