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

December 2, 2014 updated by: Enrique Gómez Barrena, Hospital Universitario La Paz

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.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • AMCHAFIBRIN
Drug: Tranexamic Acid
Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)
Other Names:
  • 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
Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
Other Names:
  • AMCHAFIBRIN
Drug: Tranexamic Acid
Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)
Other Names:
  • AMCHAFIBRIN,

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visible blood loss
Time Frame: 24 hours after surgery
Number of milliliters drained in Redon after 24 hours post OP
24 hours after surgery
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)
48 hours after surgery
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)
One month after surgery
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
participants will be followed for the duration of hospital stay, an expected average of 5 days
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
participants will be followed for the duration of hospital stay, an expected average of 5 days
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)
One month after surgery
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)
One month after surgery
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)
One month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Enrique Gomez Barrena, PI, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRANEX1

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