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

Primary Purpose

Blood Loss

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Tranexamic Acid
Tranexamic Acid
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring Total Knee Arthroplasty, TKA, blood loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Comparator

Arm Description

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. Intravenous administration of Normal saline (0.9% sodium chloride) as follow: 100mL before tourniquet realised 100mL 3 hours after surgery

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 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

Outcomes

Primary Outcome Measures

Blood transfusion rate
Number of transfused patients in each arm/Total number of patients in each arm

Secondary Outcome Measures

Visible blood loss
Number of milliliters drained in Redon after 24 hours post OP
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)
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)
Range of motion
- Range (in degrees) from full extension to full flexion during the hospital stay
Prevalence of drug-related adverse events
Rate and characteristics of the adverse events during the hospital stay
Rate of PE
Percent of PE during the hospital stay Percent of PE one month after surgery(safety reasons)
Rate of DVT
Percent of DVT during the hospital stay Percent of DVT one month after surgery(safety reasons)
Rate or Thrombophlebitis
Percent of Thrombophlebitis during the hospital stay Percent of Thrombophlebitis one month after surgery(safety reasons)

Full Information

First Posted
February 5, 2013
Last Updated
December 2, 2014
Sponsor
Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT01881568
Brief Title
Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Total Knee Arthroplasty, TKA, blood loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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. Intravenous administration of Normal saline (0.9% sodium chloride) as follow: 100mL before tourniquet realised 100mL 3 hours after surgery
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
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 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 Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
AMCHAFIBRIN
Intervention Description
Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
AMCHAFIBRIN,
Intervention Description
Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)
Primary Outcome Measure Information:
Title
Blood transfusion rate
Description
Number of transfused patients in each arm/Total number of patients in each arm
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Visible blood loss
Description
Number of milliliters drained in Redon after 24 hours post OP
Time Frame
24 hours after surgery
Title
Invisible blood loss
Description
Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75*weight(Kg)*[(Hb0-Hb1)/Hb0]+ blood transfused(mL)
Time Frame
48 hours after surgery
Title
Surgery infection rate
Description
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)
Time Frame
One month after surgery
Title
Range of motion
Description
- Range (in degrees) from full extension to full flexion during the hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Prevalence of drug-related adverse events
Description
Rate and characteristics of the adverse events during the hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Rate of PE
Description
Percent of PE during the hospital stay Percent of PE one month after surgery(safety reasons)
Time Frame
One month after surgery
Title
Rate of DVT
Description
Percent of DVT during the hospital stay Percent of DVT one month after surgery(safety reasons)
Time Frame
One month after surgery
Title
Rate or Thrombophlebitis
Description
Percent of Thrombophlebitis during the hospital stay Percent of Thrombophlebitis one month after surgery(safety reasons)
Time Frame
One month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Gomez Barrena, PI
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25471907
Citation
Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-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.
Results Reference
derived

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

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