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Completed

NCT Number: NCT01881568

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

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).

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)

Other names: AMCHAFIBRIN

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study 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.

Acronym: TRANEX1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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